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QC Specialist

1 month ago

Cork, Cork, Ireland Hovione Full time
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 off-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. Propose new methodologies taking into consideration project demands and requirements.
  5. Execute project-specific analytical tasks and act as a stakeholder liaison.
  6. Provide an example of professionalism and support the induction and training of new colleagues within the area.
  7. Ensure that all assigned 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 in a cost-effective manner.
  8. 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.
  9. 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.
  10. Review work generated by the team as required ensuring all procedures are followed.
  11. Create, investigate and evaluate CAPAs, incidents and deviations.
  12. Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments.
  13. Accurately use and maintain all laboratory information systems.
  14. Maintain good hygiene and housekeeping within the laboratory.
  15. Maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures.
  16. Fulfill and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
  17. 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.
  18. Assist with audits/investigations as required, following the instruction of QC Management.
  19. Support the generation/reporting of KPIs for the team, if required.
  20. Develop and accumulate strong analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area.
  21. Provide relevant training to other areas in accordance with established training plans.
  22. Participate, as required, in the induction and training of new colleagues.
  23. Drive high standards in the QC Laboratories.
  24. Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others.
  25. Interpret data and analysis to ensure meeting strict guidelines on documentation and recording data.
  26. Work collaboratively in cross-functional teams and understand each department's function and role in the delivery of tests and products.
  27. Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner.
  28. Propose improvements to the area as appropriate and solve problems.
  29. Make quality and timely decisions within the quality control tasks under her/his responsibility.
  30. Gather relevant data to inform the decision-makers regarding complex issues.
  31. 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).
  32. Undertake any additional tasks commensurate with the role as and when required.
  33. Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and comply with environmental, health & safety rules/procedures, regulations and codes of practice.
  34. Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
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.
  2. Typically requires 3-5 years of relevant experience in a pharmaceutical QC laboratory environment (mandatory).
  3. Hands-on experience in Analytical Chemistry and QC procedures (mandatory).
  4. Training and experience of GMP and ICH guidelines standards (mandatory).
  5. Knowledge on HPLC and GC, and familiarity with Empower Software (desirable).
  6. Strong understanding and 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. Good 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. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.

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