JOB OFFER

JOB DETAILS

Title:
Compliance Specialist
Location:
Mayo, Sligo
Job Type:
Mayo, Sligo

Compliance Specialist

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs.

We are hiring for a Compliance Specialist for the Sligo region.

Job Requirements

  • 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.
  • Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
  • Ensure that all products leaving meet the standards required for marketed and investigational drug products.
  • Ensure that products and aseptic process simulations meet the requirements of the end users, regulatory authorities and of the company.
  • Provide quality oversight during the aseptic processing of products.
  • Finished product status maintenance, including labelling as required.
  • Review/Audit of completed Batch Records.
  • Completion of Line Clearance activities.
  • Completion of Incoming Raw Material checks, including product status maintenance.
  • Review of Manufacturing Logs as required.
  • Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation as required.

Candidate Requirements

  • Degree educated in a science, quality or engineering discipline
  • Excellent knowledge of relevant GMPs, regulations and current industry trends.
  • Requires innovative thinking and a high level of attention to detail.
  • Pharma / biologics experience a distinct advantage.

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