QA Specialist

  • Westmeath
  • Temporary
  • JO-1709-62837_1505227262

Summary

Principal Responsibilities
The successful candidate will be responsible for:

  • Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to manufacturing.
  • Acts as quality point person, providing guidance and feedback on quality assurance issues.
  • Ensure relevant QA documents and procedures are approved to schedule to support technology transfers and new product introductions.
  • Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
  • Review and approval of Change control activities to ensure any impact on GMP is appropriately assessed.
  • Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
  • Supports review and approval of quality control documentation for the release of materials on site. Provides oversight of contract laboratories, as required.
  • Review and approval of manufacturing batch records to support QP release of drug product in AAMF.
  • Supports inspection readiness activities
  • Actively contributes to continuous improvement activities.
  • Any other duties as required.

Qualifications

  • A minimum of 3 years relevant experience within the pharma industry or a related field.
  • Strong knowledge of cGMP requirements for pharmaceutical manufacturing required.
  • Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
  • Excellent accuracy and attention to detail
  • Good knowledge of relevant computer packages e.g. Trackwise or similar
  • Technical writing skills required.
  • Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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