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Quality Operations Compliance Specialist

  • Division: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 24475

Our client is looking to hire a Quality Operations Compliance Specialist in Sligo on an initial 12-month contract.
Shift Hours: Hours are 8-4.30 Monday to Friday

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The Role:

  • Ensure that all products 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.

Responsibilities:

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

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

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For more information and a confidential discussion on the role of Quality Operations Compliance Specialist in Sligo, please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717