QA Specialist

  • Contract
  • Cork

Website Ref:TPM04436

Summary:
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.

Responsibilities:

  • 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.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.