Quality Assurance (QA) Compliance Specialist II

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 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).• 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.This role will be on site % working on 2 cycle shift pattern. It is Monday to Friday and will involve a week of days and a week of evenings.