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QA Manufacturing Compliance Specialist

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22231

Our client based in Sligo are looking to hire a QA Manufacturing Compliance Specialist on an initial 12 month fixed term contract.


Responsibilities:

  • Ensure that all products leaving Company XXX meet the standards required for marketed and investigational drug products.

  • Ensure that products and aseptic process simulations manufactured at Company XXX 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 products, including aseptic intervention observation.

  • 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 quality review of operations documentation (SOPs, JSTMs, Risk Assessments)

  • Completion of Line Clearance activities.

  • Completion of Incoming Raw Material checks, including product status maintenance (as required).

  • Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).

  • product status maintenance, including labelling as required.

  • Administration of Quality Logs, e.g. QA Hold, Sample Request.

  • Lead operations floor daily walk around of manufacturing areas.

  • Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.

Requirements:

  • Third level degree in a science, quality or engineering discipline.

  • A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.

  • Experience in aseptic processing gained within either a quality or operations role is highly desirable.

  • A strong knowledge of regulatory requirements is required.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717