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Defines and implements procedures and processes to assure that Hovione Computerized systems are fit for purpose and comply with applicable quality and data integrity standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and data integrity requirements to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying best practices.
- Test all computerized systems to demonstrate its compliance with internal and external guidelines (such as 21CFR Part 11, GAMP, EU, PIC/s and ICH)
- Participate in project teams that require expertise in Computerized Systems.
- Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality
- Implement the defined policies for Computerized Systems life cycle Management
- Perform validation activities of the Computerized System projects and provide the necessary guidance to ensure compliance with Regulatory and Industry Standards throughout systems’ life cycle
- Implement data integrity principles during the Computerized System life cycle, as defined
- Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Analytical equipment, Manufacturing equipment, DCS, PLC and other stand-alone software
- Issue, review and approve protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Validation of Computerized Systems and other validation/qualification documents
- Review/approve/close corporate Computerized System change controls, deviations, incidents submitted by any Department/Site, to ensure that the system is maintained in an accurate, validated, and compliant state
- Review/approve documentation regarding Computerized Systems data integrity and its life cycle management
- Provide training and coaching in quality culture and data integrity principles regarding Computerized Systems.
- Support internal, external/ customers’ audits and health authorities’ inspections.
- Perform assigned tasks as planned and deliver on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- 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)
- Supports the companywide financial planning, budgeting and forecasting process
- 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 - a realistic overall picture of all contents relevant to steer and control the business
- Supports the consolidation of the quarterly forecasting processes.
- Maintaining and further development of Company Financial Dashboard including maintenance of company KPI’s
- Build, lead, and mentor a team of functional academy leads
- Lead the development, implementation, and oversight of Hovione Functional Academies.
- Responsible for orchestrating the design, execution, deployment, and continuous improvement of functional academies aimed at enhancing the skills and capabilities of our team members across various functional areas.
- Collaborate with cross-functional teams, subject matter experts, and external partners to ensure the success of each academy.
- Oversee the design and development of curriculum for each academy, ensuring alignment with industry standards, best practices, and organizational objectives.
- Oversee and monitor the deliveries against the deployment plan, risks and mitigation actions to ensure success of each academy.
- Manages, reports and works with internal stakeholders for collaboration and alignment.
- Work closely with subject matter experts to create engaging and impactful learning materials.
- Collaborate with internal stakeholders, including functional representatives and HR, to understand specific training needs and ensure alignment with organizational objectives.
- Works with each academy lead to establish key performance indicators (KPIs) and relevant metrics for each academy (and/or key programs within each) and assess their impact on individual and organizational performance.
- 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.
- Defines and implements business processes that assess overall performance, identify business drivers, benchmark against relevant KPIs, identify improvement opportunities and promote business process optimization.
- Defines, produces timely and challenges reports that address performance against budget, profitability, cost, efficiency and risk.
- Prepare, monitor and control the annual departmental budget under responsibility to ensure expenditure is in line with the company business plan
- Administer all departmental financial and operational information in the appropriate systems
- Develop and monitor business performance metrics for the department, acting as a partner of managers and directors and understanding the department or area strategic challenges
- Execute regular and specific complex reports for the department related with operational and financial KPIs, as requested by managers and directors
- Conduct forecasts with financial and operational information
- Support project managers within the department, analyzing project costs to ensure that budgeted costs are in compliance
- Conduct specific analysis related with the department, improving data reporting and analysis
- Provide financial and accounting advice to directors and managers within the department
- Master controlling 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)
- Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product.
- Recommend the analytical characterization package (Chemical, physical, performance) and control the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies.
- Promote the 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 including: method development, method and specification creation; method transfer, protocols and reports preparation.
- Solve complex project analytical problems
- Determine the amount of work that is required to accomplish a 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 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.
- As subject matter expert you will lead multiple pharmaceutical development projects to ensure effective collaboration between internal & external stakeholders to meet the objectives of Hovione and our clients.
- Developing drug product manufacturing processes for oral drug products, including scale up, technology transfer and design space definition.
- Promote innovation by identifying, evaluating, and recommending new technologies and/or methodologies for Hovione.
- Strive to maintain Hovione as specialists in the field of Oral Drug Product Development through patents and scientific papers.
- Keep up to date with current global trends in the pharmaceutical industry, using this information to identify areas for improvement and opportunities for growth/investments.
- Select, evaluate, and make recommendations for new equipment to ensure practices and methodologies are aligned with state-of-the-art for pharmaceutical development.
- Create a knowledge sharing environment by mentoring the wider team in their experiments and by expanding their technical/theoretical knowledge and experience.