- Do global (all sites) supplier qualification services for new materials and existing materials and services.
- Deal with Suppliers and Procurement to assure the quality of the materials and components and/or operations (calibrations services, laboratory services,…).
- Manage quality agreements with suppliers: preparation, interaction with suppliers doing adjustments until an agreement is reached, workflow approval and revisions.
- Prepare and collaborate on the preparation and review of procedures, templates, aide-memoires and methodologies to standardize practices related to supplier’s qualification.
- Do supplier review assessments to assure compliance with Hovione requirements including verification of supplier questionnaires, declarations and certifications, audits output, quality agreements, quality review of materials/ service provided and feedback from other team members.
- Approve/Reapprove supplier qualification processes.
- Manage (when qualified) or participate in suppliers’ audits, executing all audit steps.
- Coach other areas of the organization on supplier qualification methodologies and requirements.
Relates to all financial management procedures and processes associated with recording, monitoring, reporting analysis and forecasting in compliance with financial obligations, accounting standards and policies to advice and support management and business units in the realization of the objectives in terms of strategy, efficiency, control, and profitability. Ensures an adequate capital structure and monitoring of enterprise risks. Actively contribute to managing profitability through the deployment of controlling best practices across the company. Responsible for the timely, accurate, and insightful analysis and reporting of financial information to key stakeholders. Drives the long-term financial planning of the company, including the investment program.
- Supports the companywide financial planning, budgeting, and forecasting process for a segment, site or a functional area
- Supports the group-wide, transparent, consistent, and uniform monthly reporting of essential business performance parameters, including business analyses and comments.
- Supports the group planning processes (target setting, long term planning and budgeting) with the goal of generating - within the defined framework and timeline - for the Management Board a realistic overall picture of all contents relevant to steer and control the business.
- Supports the coordination and consolidation of the forecasting processes.
- Work closely with managers to educate them regarding finance and accounting procedures; explore how the site finance function can support management.
- Maintaining and further development of Company Financial Dashboard including maintenance of company KPI’s
- Preparing ad-hoc financial Management Board Documentation if requested
- Supporting the development of guidelines, principles, and premises
As a member of the Assessment team, you will have a key role in the company’s business acquisition process by performing economic evaluations in close collaboration with all relevant technical areas of the Company, to build best-in-class business proposals to our clients.
- Provide timely, accurate and complete cost evaluations, covering all aspects of a business proposal for development or commercial programs/campaigns.
- Interact with all relevant internal stakeholders – sales, technical areas across all sites involved in project execution, the project manager and the bid manager.
- Fulfil the SLA (Service level Agreement), thus enabling Hovione to bid competitively, within the client's timeframe expectation.
- Apply up-to-date costing standards that reflect ambitious operational performance targets, while monitoring actual performance evolution, creating healthy tensions in light of negative evolution trends.
- Collaborate with PMs and site controllers to perform variance analysis exercises (actual vs budget) for programs and campaigns, that contribute to the continuous improvement of the costing methodologies used in the area.
- Use consistently best practices to resolve issues in effective ways aligned with company objectives and values.
Once established in the role, your contribution to the company will be shown by:
- Demonstrating specific understanding of the costing processes, workflow and interdependencies of all areas supporting the business.
- A good understanding of main unit operations at Hovione.
- A display of solid technical knowledge on use of the available Toolbox.
- Commitment to SLA and in-full deliverables to business partners and/or management.
- Proactively proposing impactful improvements to the continuous development of the Area's performance (SLA and accuracy) to processes and existing toolbox, resulting in tangible improvements in both functionality and usability.
- Consistently displaying an adequate level of autonomy to deal with complex cost evaluations on the day-to-day operations. Proactively escalating topics to senior members when appropriate to support decision. Interfacing effortlessly with peer-level technical areas across all Sites.
- Executing cost evaluations for programs under development or in commercial phase, in both existent and future installations, that account for multimillion dollars revenue.
- Understanding the materiality of multiple options in a VUCA environment.
- Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product.
- Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies.
- Promotes scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Perform project analytical tasks for complex projects: e.g., method development, method and specification creation; method transfer, protocols and reports preparation.
- Solve complex project analytical problems
- Determine scope of work and propose solutions that meet and exceed the Client’s expectations
- Discuss actively with customers on technical and scientific issues
- Prepare and discuss complex product specifications
- Conduct and supervise analytical investigations and contribute in the definition and implementation of corrective actions
- Support audits and client visits
- Evaluate and approve materials, supplier/qualification
- Master Analytical Chemistry processes and tools
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Organize and ensure the correct recording and treatment of accounting data and support the control of monthly tax obligations
- Support for the calculation and treatment of the company's tax issues
- Support for monitoring tax inspections by the Tax Authoriry
- Definition of methods and work processes in this area, as well as in the interconnection with the other areas of shared services and Treasury
- IFRS reporting support to the consolidation area
- Support for the monitoring of audit work and TAX consultancy
- Support for the supervising the entity's accounting and and preparing the respective financial statements
- Develop and maintain internal controls to support financial and accounting reports
- Reviewing the profit and loss statement, balance sheet and cash flow statement of all subsidiaries on a monthly basis;
- Analyzing all balances and transactions with related parties;
- Preparing the consolidation file and ensuring all the consolidation adjustments are proper documented.
- Preparing the report of consolidated financial statements to top management
- Preparing the annual audited consolidated financial statements, liasing with external auditors
- Identifying the key controls to be implemented in the organization
- Discussing controls to be implemented in each area of the organization and the key users
- Explaining non operational controls
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals on a regular basis. Promotes alignment by understanding and communicating business and customers’ needs and requirements through the organization.
- Locally source and procure for specific categories of indirect materials and services to ensure business alignment and guidance, compliance, stakeholder management (internal and external) and optimized categories spend.
- Develop, with the support of more senior professionals, the appropriate purchasing strategies for specific categories of indirect materials and services to ensure continuity of supply, increased productivity, reduced costs, right quality levels and regulatory & legal compliance. Proactively seek and suggest improvement opportunities.
- Develop Supplier’s relationships and trust and ensure the Company’s values are shared and aligned with Supplier’s values in order to establish long term relationships with suppliers who share values to enable the company to outperform competition.
- Provide the local organization with important insights on business, market conditions and the competitive landscape aiming at leveraging the global and local markets and differentiated sourcing strategies.
- With the relevant support, develop, right size and maintain a robust and sustainable supply base to achieve the procurement goals in terms of financial performance, supplier quality, supply chain efficiency, security and sustainability whilst establishing solid, sustainable and reliable partnerships according to the supplier segmentation.
- Establish relationships with the local key stakeholders to ensure procurement alignment with their objectives. Share and communicate the procurement strategies of the own portfolio of materials/services, gain feedback and obtain their support and resources to achieve both objectives.
- Negotiate purchasing terms and conditions to ensure optimized financial performance of purchased indirect materials and services and ensured compliance with the company's purchasing policy and working capital objectives.
- Apply and develop knowledge of procurement and participate in area processes, procedures and projects with the guidance of more senior colleagues.
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Responsibility for the identification, development, submission and management of R&D Grants/subsidies in support of the Hovione innovation strategy
- Oversees all R&D grants at Hovione globally in cooperation with areas and supports technical areas as required. Promotes the scientific excellence and innovation at Hovione.
- Ensure continuous environmental monitoring for grant and external funding opportunities at local, national, and international (EU, North America, etc) levels
- Is able to rapidly understand diverse technical fields and topics and work closely with multiple subject matter experts and external organisations to assemble grant applications with a high probability of success.
- Contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Supervise all projects within his/her portfolio, ensures that execution is flawless and that adequate resources are allocated to meet the project goals and all deliverables are met in time
- Ensure the information flow between the Hovione and grant providers/partners,
- Promote scientific excellence and innovation within the team and support in the implementation of new technologies/methodologies
- Develop and propose for management approval the strategy for grants and external funding across Hovione activities plan and related budget for the Areas in line with the company strategy, in order to align activities with strategic objectives
- Monitor budget and identify any deviations between the real and the foreseen to take corrective measures
- Ensure compliance with grant guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals on a regular basis. Promotes alignment by understanding and communicating business and customers’ needs and requirements through the organization.
- Source and procure for specific categories of indirect materials and services to ensure business alignment and guidance, compliance, stakeholder management (internal and external) and optimized categories spend.
- Develop, with the support of more senior professionals, the appropriate purchasing strategies for specific categories of indirect materials and services to ensure continuity of supply, increased productivity, reduced costs, right quality levels and regulatory & legal compliance. Proactively seek and suggest improvement opportunities.
- Develop Supplier’s relationships and trust and ensure the Company’s values are shared and aligned with Supplier’s values in order to establish long term relationships with suppliers who share values to enable the company to outperform competition.
- Provide the local organization with important insights on business, market conditions and the competitive landscape aiming at leveraging the global and local markets and differentiated sourcing strategies.
- With the relevant support, develop, right size and maintain a robust and sustainable supply base to achieve the procurement goals in terms of financial performance, supplier quality, supply chain efficiency, security and sustainability whilst establishing solid, sustainable and reliable partnerships according to the supplier segmentation.
- Establish relationships with the local key stakeholders to ensure procurement alignment with their objectives. Share and communicate the procurement strategies of the own portfolio of materials/services, gain feedback and obtain their support and resources to achieve both objectives.
- Negotiate purchasing terms and conditions to ensure optimized financial performance of purchased indirect materials and services and ensured compliance with the company's purchasing policy and working capital objectives.
- Apply and develop knowledge of procurement and participate in area processes, procedures and projects with the guidance of more senior colleagues.
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Increases sales team effectiveness by providing appropriate tools, processes and support. These include managing the bidding process and the RFI process, managing the CRM system and the demand review process, providing sales analytics and reporting, supporting the sales forecasting process, providing training about Hovione offerings, and supporting with business operations activities.
- Participate in the creation of the department strategy and planning, co-creating the strategy and procedures for assessment & 3P area in alignment with business goals.
- Guarantee that the assessments are conducted in a timely and efficient way, maximizing the profitability.
- Oversee the activities of the TM’s, giving direction in complex projects.
- Coordinate multi-site economic evaluations and 3P of products under VUCA, leading others in the elaboration of business proposals, project budgeting and variance analysis.
- Develop and/or approve the economic evaluations processes of the area, including defining and monitoring the SLA’s.
- Guarantee the necessary inputs for complex economic evaluations from internal stakeholders at all sites, leading interactions with key people internally.
- Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with sales enablement department strategic objectives.
- Monitor the Assessment & 3P´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Lead the technical aspects of multiple complex projects
- Assess different options and recommends an approach to deliver on the agreed work plan
- Provide troubleshooting support to less experienced Team Members
- Generate technical documentation related to own projects and review others
- Provide technical assessment of new projects as well as technical support to other areas
- Actively propose improvements of processes and procedures
- Generate Intellectual Property and promote scientific activities & innovation
- Develop/propose new methodologies/technologies to increase R&D efficiency
- Contribute to Hovione branding by actively participating in Scientific Events, speaking at conferences, etc
- Act as lead in inspections and internal and external audits related to R&D projects
- Represent Hovione with clients during technical and business assessments
- Network with senior internal/external personnel outside own area of expertise
- Act as a resource and mentor to TMs in own areas of technical expertise
- Train others in subjects related to own area specifics/expertise
- Master scientific investigation processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
- Ensure Talent Management strategies that align with our business goals;
- Guarantee that organization-wide Talent Management and initiatives are focused and aligned on improving operational and program efficiencies and effectiveness;
- Provide expertise and support in the design, development, and implementation of the talent review process;
- Lead the annual talent identification process, partnering with senior leaders to create and implement development plans;
- Develop, initiate and maintain effective programs for workforce retention, promotion and succession planning;
- Manage the performance management system; plan and implement the company's annual performance management process;
- Support and lead holistic organizational design diagnostics, identifying thematic operating improvement themes to support business case drafting and internal investment process;
- Use organizational design methodologies and principles to form future-state people & location strategies that deliver on business and functional objectives;
- Manage cross functional projects.
- Conceive, design and implement engineering solutions on the specific areas of engineering projects, towards a successful project conclusion, in order to achieve the company established objectives;
- Prepare, revise and approve technical documentation of Engineering Projects, for conceptual, basic and detailed design phases;
- Ensure that project documents are complete and optimal for a competitive tender process;
- Prepare the project budget & timeline, and control them during execution;
- Supervise the construction, installation, commissioning and qualification of assigned projects, within is area of responsibility;
- Support the internal and external Engineering teams, integrating the work with other specialties into the final project solution, assuring user deadlines are met and without unexpected delays in production;
- Work with the other Engineering areas and project management to resolve project issues, ensuring the delivery/completion of the project work;
- Capture user feedback and lessons learned for future projects;
- Propose improvements (procedures, organizational, new technologies, capex, productivity) in Engineering as appropriate;
- Make quality and timely decisions within the Design Engineering tasks under his/her responsibility;
- Create and select the technical documentation to be used as a learning tool for new engineers, a reference for future projects and a historical repertoire (e.g., for assessments and investigations).
- Design, project coordinarion and execution/qualification of strategic projects across all sites as part of the Global Engineering team;
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Performs automation and qualification activities on facilities, equipment and utility systems, according to regulatory demands (cGMP, GAMP, FDA requirements, etc), industry applicable guidelines and internal procedures;
- Planning, executing and supervising new or business continuity projects (MS Project, Meeting project deadlines and operation targets, milestones);
- Prepare Project Budgets and Coordinate outside contractors working on facility projects;
- Proactively develop, maintain, drive and communicate project timelines to broader cross-functional team on a weekly basis.
The IA Senior Manager will lead the audit work and staff, interface with management and generally perform and review required fieldwork. They will execute audits in all locations of the company (this is a global role) to review and evaluate the effectiveness of the internal controls, reliability of the financial reporting as well compliance with internal standards and external laws and regulations.
The role involves up to 10% of travelling time depending on the audit assignment and is a hybrid job position.
- To assess adequacy of internal controls, efficiency and effectiveness of business processes, including identification of control gaps and recommendations for improvement opportunities arising from audit engagements.
- To plan, manage and execute audit assignments as per Annual Audit Plan.
- To review and finalize audit working papers and audit findings prepared by audit team members.
- To manage audit assignments, report progressively on status of engagement and ensure completion of audit assignment as per the Annual Audit Plan / agreed timeline.
- To supervise and assist team members in overall execution of targeted testing and risk assessments.
- To review and discuss audit findings, recommendation and corrective action plan with responsible personnel, process owner and relevant stakeholder.
- To perform follow up audit on findings reported to ensure management action are implemented accordingly.
- To periodically engage members of the management team, stay ahead with Company and industry developments and make adjustments to the internal audit activity, if .
- To perform any ad hoc assignments and projects as necessary.
- Establish annual plans for improvement in accordance with past performance and company strategic goals;
- Define long term targets for Business Transformation Implementation;
- Mentor and facilitate teams that are implementing projects and problem solving;
- Coach functional area teams in their daily communication meetings, ensuring that defined methods are properly used in all areas;
- Coach Lean Leaders and/or Six Sigma Green Belts;
- Develop Operational Excellence Training Program and run training sessions across all levels of the company;
- Develop a Continuous Improvement (CI) process in the plant that is visible to all e.g. through indicators, working methods and visual management;
- Lead projects that result in major business process improvements for the company;
- Track and report project results to management, internally and externally;
- Work closely with Project Sponsor and Operational Excellence Director to continuously review process and to eliminate barriers in projects;
- Ensure that process improvements stay in place over time and assure their sustainability;
- Develop site culture initiatives to establish and maintain the operational excellence culture;
- Support the execution of Operational Excellence Maturity Assessment and other benchmarking exercises;
- Manage complex projects with significant impact on business;
- Make quality and timely decisions based on multiple sources of data.
Leading the team of Strategic Alliances as line manager reporting to the VP Business Transformation & Licensing
Develop and nurture a network of contacts in order to establish strategic partnerships with Universities, startup companies, business associations, and other relevant market or scientific players in areas defined as strategic for Hovione.
Manage the network in a comprehensive business development database
Identify internal challenges and unmet needs and find new solutions and new partners to solve problems and improve products and/or processes.
Identify, through the network of contacts, external solutions that may resolve internal needs or answer to unmet market needs that may become opportunities for Hovione
Perform preliminary evaluation of the potential partners and/or solutions based on defined processes and criteria.
Attend international meetings and conferences scouting for opportunities and presenting Hovione’s strengths and objectives as a partner
Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead partnering project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Optimizing partner satisfaction and securing long-term successful partnerships are central to the function.
- Organize the projects and partnerships under responsibility in accordance with the mission and goals of Hovione, giving direction to project managers and supporting the resolution of complex issues, guaranteeing projects are delivered according to the assigned criteria (output, budget and timings)
- Propose new partnering projects and elaborate preliminary budgets, teams, activity plan and deadlines
- Propose and control long-term goals for the partnerships under responsibility, guaranteeing that partnerships follow a path in the appropriate direction
- Apply an evaluation method for the partnerships under responsibility to assess the partnerships’ successfulness and identify areas for improvement, analyzing risks and controlling KPIs
- Act as a facilitator of partnership projects, joining stakeholders and communicating key aspects of the partnerships
- Produce complex partnership status and KPIs reports and present it as requested
- Participate in strategic forums to discuss the future direction of Hovione’s collaborations and projects, contributing with analysis and insights
- Manage the TMs assigned to his/her/its area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity
- Develop and propose for approval the short and mid-term goals, annual budget and budget plan for the partnerships and projects under responsibility in line with the corporate strategy, in order to align activities with Hovione strategic objectives
- Prepare and propose for superior approval the annual budget of partnerships and projects under responsibility, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- Comply with all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/her/its TMs
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Perform and provide support to the development of analytical methods and the implementation of innovative and new analytical methodologies
- Coordinate priorities with Area responsible and Project manager to ensure that the timelines of the analytical work (such as method development, validation protocols, validation execution, and validation reports) of the project are met
- Prepare and revise analytical reports and protocols
- Actively participate in investigations and propose corrective and preventive actions (CAPA)
- Discuss actively with customers technical and scientific issues of projects under own scope
- Support client visits
- Discuss and review analytical data generated by the team
- Provide training internally and to other areas as required
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- Make quality and timely decisions within the Analytical tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Perform and provide support to the development of analytical methods and the implementation of innovative and new analytical methodologies
- Coordinate priorities with Area responsible and Project manager to ensure that the timelines of the analytical work (such as method development, validation protocols, validation execution, and validation reports) of the project are met
- Prepare and revise analytical reports and protocols
- Actively participate in investigations and propose corrective and preventive actions (CAPA)
- Discuss actively with customers technical and scientific issues of projects under own scope
- Support client visits
- Discuss and review analytical data generated by the team
- Provide training internally and to other areas as required
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- Make quality and timely decisions within the Analytical tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Provide inspirational leadership to the team and strive for operational excellence, with higher quality, efficiency and at higher processing speed.
- Drive best practice and process efficiencies through continuous improvement increase overall efficiency;
- Benchmark shared services organization against other companies to identify and implement process improvements
- Identify and implement process and system improvements to
- Develop and provide KPIs and metrics to senior management
- Monitor the process of invoice posting for local and foreign vendors and liaising with third parties in case of irregularities
- Monitors vendor current account reconciliation with monthly statements and liaises with external auditors in this matter
- Provide technical guidance and assist less senior TM’s
- Provide guidance and support to colleagues informally
- Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes.
- Act as a subject matter expert to less experienced colleagues.