QA Manufacturing Compliance Specialist

  • Sligo
  • Collins Mcnicholas

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, sample pulls, weekly checks, protocol generation (as required).
  • product status maintenance, including labelling as required.
  • Administration of Quality Logs, 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