QA Operations Manager

QA Operations Manager - Co Sligo

Our clients mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

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 meet the regulatory requirements for patient safety and efficacy and comply with Regulatory Authority Requirements that the product is been released too.

In this role you will:

• Ensure that all NPI and Commercial Products manufactured 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.
• 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 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.
• Liaise with global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies (where applicable).

Ideally you will have:

• Degree level qualification in a science discipline with previous experience in the healthcare/pharmaceutical industry.
• M Sc 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.