QC Associate Loures

QC Associate
Loures
Loures, Lisboa, Portugal

Join a Market Leader

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and
- patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

You will be responsible to:

1. Define and implement quality control techniques 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.
2. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
3. Rigorously manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards/procedures and legal regulations, escalating as appropriate.
4. Guide less experienced colleagues in undertaking assigned project tasks.
5. Propose new methodologies considering project demands and requirements.
6. Execute
   - specific analytical tasks and act as a stakeholder liaison.
7. Provide an example of professionalism and lead the induction and training of new colleagues within the area.
8. Ensure that all analytical tasks, including method development, method creation, method transfer, method validation, protocol preparation, and report preparation, are well managed and delivered on time, safely, efficiently, reliably, and
   - effectively.
9. Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments.
10. Ensure effective and proactive flow of information between the Analytical team and internal/external stakeholders.
11. Review work generated by the team ensuring all procedures are followed.
12. Create, investigate, and evaluate CAPAs, incidents, and deviations.
13. Perform equipment maintenance, internal calibrations, and internal qualifications on designated laboratory instruments.
14. Accurately use and maintain all laboratory information systems.
15. Maintain good hygiene and housekeeping within the laboratory.
16. Maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard.
17. Fulfill and promote all applicable GMP requirements and HSE regulations.
18. Be a leading advocate for safe operating and
    - quality performance.
19. Proactively assist with audits/investigations as required.
20. Collaborate with management in developing, generating, and proactively reporting KPIs for the team.
21. Maintain advanced analytical chemistry expertise and share knowledge of new technologies and methodologies.
22. Lead relevant training delivery to other areas and support development of training plans.
23. Drive high standards in the QC Laboratories.
24. Use and support others on the use of analytical techniques and instrumentation, such as gas and
    - performance liquid chromatography (HPLC).
25. Interpret data and analysis to ensure strict guidelines on documentation and recording data are met.
26. Work collaboratively in
    - functional teams.
27. Master Quality control processes and tools.
28. Manage complex projects/analysis with significant impact on business.
29. Make quality and timely decisions based on multiple sources of data.
30. Manage risk and uncertainty; anticipate and escalate roadblocks.
31. Carry out assigned tasks and duties in a safe manner.
32. Execute professional activities in compliance with GMP and HSE guidelines.
33. Undertake any additional tasks commensurate with the role.

We are looking to recruit a Candidate:

1. Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field (mandatory).
2. Typically requires 5-8 years of relevant experience in a pharmaceutical QC laboratory environment (mandatory).
3. Strong
   - on experience in Analytical Chemistry, Development and Validation of analytical methods and QC procedures (mandatory).
4. Advanced training and experience of GMP and ICH guidelines standards (mandatory).
5. Good working knowledge on HPLC and GC, and familiarity with Empower Software (mandatory).
6. Advanced knowledge of GMP practices, analytical theory and techniques.
7. Fluency in English is a requirement.
8. Computer literate with good working knowledge of the MS Office package.
9. Strong documentation skills and attention to detail.

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect.