A QA Specialist is required for a biopharmaceutical company in Cork. The successful candidate will join the QA Manufacturing and Facilities Support team. This incumbent will perform QA review of manufacturing and engineering records & associated documents and QA review & approval of procedures and GMP deviations.
- Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.
- Reviews routine manufacturing and engineering documentation including batch manufacturing records.
- Assists in the completion of Manufacturing related customer complaint investigations.
- Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
- Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions.
- Review and approval of GMP Deviation investigations and CAPAs.
- Identifies problems and generates alternatives and recommendations.
- Completion of routine/non-routine to more complex projects/assignments.
- Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP.
- Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings.
- Normally receives very little instruction on routine work, general instructions on new assignments.
Qualifications & Experience:
- 4+ years of relevant experience in a GMP environment related field and a BS.
- 3 + years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred (ideally within a QA role).
- Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems).
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
- Proficiency in Microsoft Office applications.
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