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Performs maintenance on equipment and systems (e.g., mechanical, electrical). Evaluates and recommends equipment improvements to increase reliability, capability and yield. Performs equipment condition analysis (during preventive and unscheduled maintenance). Troubleshoots and diagnoses equipment problems / failures. Prepares technical reports to document equipment modifications and equipment maintenance procedures.
- Ensure the maintenance, service, repair and troubleshoot of all equipment and installations (mechanical / electrical / instrumentation) on site is performed as per Standard Operating Procedures, Maintenance work instructions or engineering best practices
- Participate in risk assessment of work permits and control of their appropriate execution
- Actively participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D)
- Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA)
- Assist in the training of more junior members of the maintenance area in their area of expertise
- Ensure the correct completion of all required documentation, paper or system based, associated with own and area work
- Ensure proper tidiness and cleanliness of the maintained equipment and area as well as of his/her working area
- Ensure that area or his/her assign tolls are kept in good shape in what regards to their functionality and cleanliness
- Collaborate in the analysis / investigation of irregularities or CAPAs pertaining to area
- Ability to choose the appropriate methods or tools
- Ability to provide training and support colleagues
- Follow established procedures and processes, with the ability to interpret instructions, drawings and equipment technical documentation
- Resolve non-complex problems related to discipline, with more complex issues being referred to line manager or technical team member.
- Adapt to changing site priorities Support other team members in prioritizing work
- 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
- Ensure facility activities are carried out in compliance with all GMP, legal and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice
- 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
- Undertake any additional tasks commensurate with the role as and when required.
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs.
- To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system.
- Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
- To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures.
- To maintain good hygiene and housekeeping within the laboratory.
- To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
- Comply with the high standards in the QC Laboratories.
- To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
- To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories.
- Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms.
- Assist with audits as required, following the instruction of QC Management.
- Undertake any additional tasks to support the laboratory activities as and when required.
- Seek out additional information when one feels that the available information is not enough.
- Follow all annual performance review requirements, including completion of the self-assessment.
- 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 facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- Rigorously, accurately, efficiently and professionally manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards / procedures and legal regulations, escalating as appropriate
- Propose new methodologies taking into consideration project demands and requirements
- Execute project specific analytical tasks and act as a stakeholder liaison
- Provide an example of professionalism and support the induction and training of new colleagues within the area
- Ensure that all assigned analytical tasks, including (but not limited to) method development, method creation, method transfer, method validation, protocol preparation and report preparation, in any analytical project is well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning
- Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period
- Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team as appropriate
- Reviews work generated by the team as required ensuring all procedures are followed
- Creation, investigation and evaluation of CAPAS, incidents and deviations
- Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments
- Accurately use and maintain all laboratory information systems
- To maintain good hygiene and housekeeping within the laboratory
- To maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures
- Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities
- Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements
- Assist with audits / investigations as required, following the instruction of QC Management
- Support the generation / reporting of KPIs for the team, if required
- Develop and accumulate strong analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area
- Provide relevant training to other areas in accordance with established training plans
- Participate, as required, in the induction and training of new colleagues
- Drive high standards in the QC Laboratories
- Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others
- Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data
- Work collaboratively in cross-functional teams and understand each departments function and role in delivery of tests and products
- 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 quality control 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)
- Undertake any additional tasks commensurate with the role as and when required
- 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.
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
- Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments;
- Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team (with support from senior colleagues) as appropriate;
- Reviews work generated by the team as required ensuring all procedures are followed;
- Creation, investigation and evaluation of CAPAS, incidents and deviations;
- Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments;
- Accurately use and maintain all laboratory information systems;
- Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities;
- Assist with audits / investigations as required, following the instruction of QC Management;
- Support the reporting of KPIs for the team, if required;
- Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others;
- Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data;
- Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
- Develop & Maintain a competences framework covering the areas of Health Safety & Sustainability (HSS).
- Establish and maintain HSE Academy curricula appropriate to risks and regulatory requirements and aligned with Global and Site needs.
- Working with stakeholders, establish and lead a governance process for the development of transversal training content to maximize efficiency and effectiveness and support as necessary the development of site/function specific content as needed.
- Working with stakeholders establish and lead a governance process for the approval of trainers for the HSE Academy ensuring trainers have the appropriate experience, knowledge, and competency to deliver assigned training.
- Develop and review as appropriate learning support materials for trainers to ensure transversal training is delivered in a manner which is consistent across the company.
- Work the Global Human Resources and Learning & Development to ensure the effective roll out and operation of the Hovione Learning Academy.
- Monitor Performance KPIs for L&D within HSE and generate training status reports for management.
- Develop and propose for approval an annual activity plan and related budget for the Area under responsibility in line with the unit's strategy, to align activities with the department strategic objectives
- Monitor the approved HSE L&D budget, identifying any deviations against plan and taking corrective measures as necessary.
- Promote the introduction of innovative Learning & Development methodologies or technologies during the revision and implementation of the training contents.
- Promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures, and training.
- Working with stakeholders and in alignment with Global Communications, develop and lead the implementation of a communication plan in support of company objectives in the areas of Health, Safety & Sustainability.
- Support the work Global Health Safety & Sustainability.
- Define, propose for approval and guarantee the implementation of strategies for the areas under responsibility (Health, Safety and/or Environment), as well as action plans
- Act as an adviser for top management in the HSE areas of expertise
- Set targets for the areas of expertise, developing plans to meet those targets and overseeing their delivery
- Guarantee the effective implementation of appropriate HSE procedures in the areas of expertise, guaranteeing its updating in line with changes in legislation, regulation and company directives
- Oversee internal and external audits in the HSE areas of responsibility
- Propose the implementation of new measures and procedures related with the HSE areas of expertise to ensure the mitigation of risks
- Take part in accident / incident investigating, guaranteeing the identification of a root cause and the elaboration of mitigation plans
- Oversee the elaboration of management reports, briefings and KPI analysis as requested in the areas of expertise
- Guarantee the conduction of in-house training on the assigned areas of expertise
- Ensure risk assessment in the areas of expertise
- Maintain an extensive knowledge of the legislation and updates in the areas under responsibility
- 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 department strategic objectives
- Monitor own´s budget and Capex, 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.
- To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures, and training.
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- Plan, coordinate and supervise the work, with other managers of the area, and manage own team to ensure that the deliverables of each project are dealt in the team within the timeframes defined, with the appropriate quality and according to cGMP and that an outstanding service is provided to all customers (internal and external)
- Assure that all TMs of the team have suitable training in order to guarantee the best possible support to the customer (internal and external)
- Ensure an appropriate information flow between the laboratory and the several internal and external customers
- Participate in external and internal audits
- Approve analytical test methods, reports, protocols and other documents related to the laboratory (as applicable)
- Approve raw material, intermediate and finished product batches, stability samples, validations and/or all samples sent for QC to perform analysis
- Approve In Process and COL samples when necessary
- Assure the availability of International standards and Hovione internal working standards with adequate calibrations/qualifications
- Manage International/In-house Primary and Secondary/Clients' standards and reserve/retention samples
- Assure the qualification of the laboratory equipment and validation of analytical methods, approving the protocols and / or respective reports
- Discuss and propose specifications for raw materials, and intermediate and finished products
- Ensure proper management of all defined stability programs in terms of protocol preparation, inventory management, analytical testing execution and data release
- Ensure that corrective and preventative actions are defined and implemented as a result of deviations occurred in the Area, and of internal and external audits
- Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences
- Assure the timely execution of the preventive maintenance program and execution of corrective maintenance.
- 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 area strategic objectives
- Monitor Communication´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.