QA Operations Manager

Reporting to the QA Director, the QA Operations Manager will ensure that sterile products (New Product Introduction (NPI) and Commercial) are manufactured, filled and released at AbbVie Biologics Ballytivnan (ABB) meet the regulatory requirements for patient safety and efficacy and comply with Regulatory Authority Requirements that the product is been released too.

Main duties and responsibilities

• Ensure that all NPI and Commercial Products manufactured at AbbVie Biologics are in accordance with the relevant GMPs.
• Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial manufacturing processes within AbbVie Biologics.
• Management of site QPs and Manufacturing Quality Assurance (MQA), including NPI and Commercial batch release, product performance and regulatory support.
• Ensuring that sterile and aseptic products manufactured at ABB meet requirements of end users, Regulatory Authorities and of the company.
• Verify that batches are manufactured and comply with the provisions of the marketing authorisation.
• Ensure manufacture has been carried out in accordance with all applicable Good Manufacturing Practice, e.g., EU GMP Annex 1 and FDA regulations.
• Ensure the principal manufacturing and testing processes have been appropriately validated; account has been taken of the actual production conditions and manufacturing records.
• Confirm that any exceptions or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
• Maintain knowledge and experience is up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
• Liaise with AbbVie global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies (where applicable).
• Liaise with AbbVie Product Quality, S&T and Regulatory affairs function in relation to product filing support.
• Ensure effective transfer of NPIs to site and its progress into clinical / commercial manufacturing
• Work with QA Director, Quality Control and Quality Systems group to ensure site meets its customer, quality service, regulatory and financial goals.
• Degree level qualification in a science discipline with previous experience in the healthcare/pharmaceutical industry.
• MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• Industrial experience gained in a FDA and EMA approved pharmaceutical environment.
• Previous supervisory and managerial experience in a manufacturing related area in a Biotechnology, Pharmaceutical or Medical Device organisation
• Experience in manufacturing processes of drug product/substance, including aseptic filling, visual inspection of drug product, solutions preparation, and sterilization operations preferable.
• Proven track record in audit management and regulatory interaction management.

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