QA Manufacturing Compliance Specialist

7 days ago


Sligo, Sligo, Ireland TEAM HORIZON Full time

At Team Horizon, we are seeking an experienced QA professional to join our aseptic facility as a QA Manufacturing Compliance Specialist.

This is an important role within the business and will provide quality and compliance oversight and assistance to the Operations function.

We offer the opportunity to provide real-time shop floor oversight to Aseptic operations, both manufacturing, sampling and testing, partnering with Site colleagues to create an environment of the highest performance standards and drive continuous improvement on site.

The successful candidate will ensure that all products leaving the facility meet the standards required for marketed and investigational drug products.

Key Responsibilities:

  • Ensure that products and aseptic process simulations manufactured meet the requirements of the end users, regulatory authorities and of the company.
  • Provide 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.


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