Job Description
QA Manufacturing Compliance Specialist (Biologics)
Responsibilities:
- Ensure that all products leaving AbbVie Biologics Ballytivnan meet the standards required for marketed and investigational drug products.
- Ensure that products and aseptic process simulations manufactured at AbbVie Biologics Ballytivnan 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 noncompliance.
- 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.
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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