QA Specialist

  • Contract
  • Cork

Website tpm05517

Summary:
A QA Specialist is required for a biopharmaceutical company in East Cork. 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.

Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements.
  • Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
  • Participates in reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
  • Performs QA review and release of primary and secondary packaging components.
  • Performs QA review and approval of artwork.
  • Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
  • QA Review and approval of GMP Deviation investigations and CAPAs.
  • QA Review and approval of Master data and recipes required for operations.
  • May participate in data gathering exercises, to develop and maintain QA metrics.
  • Participate in compliance improvement projects, Strategic, Technical and Operational Excellence projects and represents the QA function at relevant cross-functional meetings.
  • May assist with compliance audits and walkthroughs as required on behalf of the QA department to ensure site compliance to GMP.
  • May work with secondary packaging contract organisation and perform QA review and approval of associated documents, i.e. complaints, packaging instructions, change controls.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
  • Normally receives very little instruction on routine work, general instructions on new assignments.

Qualifications & Experience:

  • Relevant degree.
  • 3/4+ years of relevant experience in a GMP environment.
  • Prior experience in pharmaceutical industry is preferred (ideally within a QA role).
  • Demonstrates working knowledge of current Good Manufacturing Practices (cGMPs).
  • Demonstrates proficiency in application of QA principles, concepts, industry practices and standards.
  • Demonstrates working knowledge of FDA / EMEA standards and quality systems.
  • Demonstrates 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.
  • Proficiency in Microsoft Office applications.

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