Hovione is a leading contract development and manufacturing company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market.
Job Description
* We are seeking an analytical professional with expertise in quality control techniques to join our team. This individual will 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.
* The successful candidate will be responsible for managing and controlling all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
Main Responsibilities:
1. We are looking for a detail-oriented individual who can apply and develop knowledge of Quality Control and participate in area processes, procedures and projects with the guidance of more senior colleagues.
2. The ideal candidate will 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.
3. New methodologies should be proposed taking into consideration project demands and requirements.
4. Project specific analytical tasks will be executed and the candidate will act as a stakeholder liaison.
5. A professional example should be provided and support will be given to the induction of new colleagues within the area.
6. 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 should be well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning.
7. Analytical problems relating to assigned projects should be solved 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
8. The effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders should be ensured, representing the team (with support from senior colleagues) as appropriate.
9. The work generated by the team will be reviewed as required ensuring all procedures are followed.
10. CAPAS, incidents and deviations will be created, investigated and evaluated.
11. Laboratory instruments designated will have equipment maintenance, internal calibrations and internal qualifications performed.
12. All laboratory information systems will be accurately used and maintained.
13. Good hygiene and housekeeping within the laboratory should be maintained.
14. Laboratory records, project and general logbooks and notebooks should be maintained to an acceptable GLP standard and in accordance with Hovione internal procedures.
15. GMP requirements and HSE regulations should be fulfilled and promoted, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
16. Safe operating and high-quality performance should be advocated, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements.
17. Audits / investigations may require assistance, following the instruction of QC Management.
18. KPIs for the team may be supported in reporting if required.
19. Strong analytical chemistry expertise should be developed and accumulated.
20. High standards in the QC Laboratories should be maintained.
21. Analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others, should be used.
22. Data interpretation and analysis should ensure meeting strict guidelines on documentation and recording data.
23. Cross-functional teams should be worked collaboratively in and understand each departments function and role in delivery of tests and products.
24. All assigned tasks should be performed to ensure they are delivered on time, safely, efficiently, reliably and in a cost-effective manner.
25. Professional activities should be executed 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).