QA Specialist

  • Contract
  • Cork

Website TPM05381

Summary:
A QA Specialist is required for a biopharmaceutical company in East Cork. The incumbent will perform the QA review of manufacturing and engineering records and associated documents. The successful candidate will also perform the QA review and 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:

  • Relevant degree.
  • 3+ years of relevant experience in a GMP environment related field.
  • 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.
  • Demonstrates audit and investigation skills, and report writing skills.
  • Good verbal, written, and interpersonal communication skills.
  • Proficiency in Microsoft Office applications.

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