QA Compliance Specialist

3 weeks ago


Sligo, Ireland Headcount Solutions Limited Full time

QA Manufacturing Compliance Specialist (Biologics)Rotating Day and Evening Shift.We are actively seeking to recruit a QA Compliance Specialist to become a key member of the Quality Team within a West of Ireland based Pharma manufacturer. This is an on site role with a rotating day and evening shift pattern.Responsibilities• Ensure that all products leaving the site meet the standards required for marketed and investigational drug products.• Ensure that products and aseptic process simulations manufactured on site 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 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).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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