QA Compliance Specialist
Posted 5 days ago by Headcount Solutions Limited
QA Manufacturing Compliance Specialist (Biologics)
rotating day and evening shift
An career advancing opportunity has arisen for a QA Compliance Specialist within a Pharmaceutical Manufacturing leader based in the West of Ireland
Responsibilities
• 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.
- Type:
- Contract
- Contract Length:
- N/A
- Contact Name:
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- Telephone:
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- Job Reference:
- NHAM01
- Job ID:
- 222413661
- Applications:
- Less than 10
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