JOB OFFER

JOB DETAILS

Title:
Manufacturing Compliance Specialist
Location:
Sligo
Job Type:
Sligo

Manufacturing Compliance Specialist

Manufacturing Compliance Specialist

Job Description

  • 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.
  • 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 Line Clearance activities.
  • Completion of Incoming Raw Material checks, including product status maintenance.
  • Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation as required.
  • Finished product status maintenance, including labeling as required.
  • Administration of Quality Logs, e.g. QA Hold, Sample Request, VCR.
  • 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.

Qualifications and Experience:

  • A third level qualification in a science, quality or relevant discipline
  • At least 2 years experience in a similar position
  • Strong knowledge of the regulatory requirements
  • Strong communication skills both verbal and written

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