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QA Manufacturing Compliance Specialist (Biologics)

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 23096

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 the site 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 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).
  • Finished 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.
  • Other support as deemed necessary.

Requirements

  • Third level degree in a science, quality or engineering discipline.
  • Ideally previous experience in a quality role
  • 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