Manufacturing Compliance Specialist
Job Type:

Manufacturing Compliance Specialist

GerTEK Project Management & Technical Services is seeking to recruit a Manufacturing Compliance Specialist to join our team.

Job Description

  • Ensure that all products leaving meet the standards required for marketed and investigational drug products.
  • Ensure that products and aseptic process simulations manufactured meet the requirements of the end users, regulatory authorities and of the company.
  • Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
  • Provide quality oversight during the aseptic processing of product Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
  • Review/Audit of completed Batch Records.
  • Review of Manufacturing Logs as required.
  • Completion of Line Clearance activities.
  • Completion of Incoming Raw Material checks, including product status maintenance.
  • Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation as required.
  • Finished product status maintenance, including labelling as required.
  • Administration of Quality Logs, e.g. QA Hold, Sample Request, VCR.
  • Lead operations floor daily walk around of manufacturing areas.
  • Drive continuous improvements and simplify site processes and procedures, specifically relating to the Operations function to ensure compliance is maintained at all times.

Qualifications and Experience

  • A third level qualification in a science, quality or relevant discipline
  • At least 5 years’ experience in a similar position
  • Strong knowledge of regulatory requirements
  • Quality systems experience and familiar with vendor evaluation, qualification, coordination of change management process etc.

Shift work required


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