Job Description
A QA Specialist is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical Company.
This is a contract role for a QA Specialist, within the QA Department under the QA packaging and labelling support team. The successful candidate will be required to perform QA approval and release of primary and secondary packaging components, QA review and approval of packaging and labelling documents, procedures, and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment within well-defined and established procedures and practices to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
THE ROLE
* Performs a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements.
1. Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure
quality objectives are met.
2. Participates in reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
3. Performs QA review and release of primary and secondary packaging components.
4. Performs QA review and approval of artwork.
5. Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
6. QA Review and approval of GMP Deviation investigations and CAPAs
7. QA Review and approval of Master data and recipes required for operations
8. May participate in data gathering exercises, to develop and maintain QA metrics.
9. Participate in compliance improvement projects, Strategic, Technical and Operational Excellence projects and represents the QA
function at relevant cross-functional meetings.
10. May assist with compliance audits and walkthroughs as required on behalf of the QA department to ensure site compliance to GMP.
11. May work with secondary packaging contract organization and perform QA review and approval of associated documents, i.e.
complaints, packaging instructions, change controls.
12. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
13. Normally receives very little instruction on routine work, general instructions on new assignments.
REQUIREMENTS
Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
14. Demonstrates working knowledge of current Good Manufacturing Practices (cGMPs).
15. Demonstrates proficiency in application of QA principles, concepts, industry practices and standards.
16. Demonstrates working knowledge of FDA / EMEA standards and quality systems.
17. Demonstrates basic knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations.
18. Demonstrates audit and investigation skills, and report writing skills.
19. Good verbal, technical writing and interpersonal skills.
20. Proficiency in Microsoft Office applications.
21. 4+ years of relevant experience in a GMP environment related field and a BS
22. 3+ years of relevant experience and a MS
23. Prior experience in pharmaceutical industry is preferred.
24. Positive attitude and enjoys working as part of a team
25. Resilient profile with the ability to deliver in a challenging environment
26. Ability to engage and manage multiple stakeholders to achieve the objective
27. Curious with learning agility
28. Operationally excellent
29. Organised with systematic approach to prioritisation
30. Process orientated to achieve the business objective