Quality Assurance
2 weeks ago
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Quality Assurance (QA) Compliance Specialist II, SligoClient: Cpl
Location: Sligo, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: a5f70a0f49fd
Job Views: 82
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:Responsibilities- Ensure that all products leaving Biologics Ballytivnan meet the standards required for marketed and investigational drug products.
- Ensure that products and aseptic process simulations manufactured at Ballytivnan meet the requirements of the end users, regulatory authorities, and 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.
- Lead/Assist in investigations arising out of product or manufacturing processes non-compliance.
- Review/Audit of completed Batch Records.
- Review of Manufacturing Logs as required.
- Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
- Complete Line Clearance activities.
- Complete Incoming Raw Material checks, including product status maintenance (as required).
- Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
- Administer 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.
- 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.
This role will be on site, working on a 2 cycle shift pattern. It is Monday to Friday and will involve a week of days and a week of evenings.
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