Senior Manager, Product QA
Our client, a global biopharmaceutical organisation based in Sligo, are currently recruiting for a Senior Manager, Product QA to join their team on a permanent basis. As Senior Manager you will to lead a technical team of 6 experienced Quality and Regulatory professionals, including 3 QPs. The successful candidate will be responsible for the release of all finished products from the site across API and Drug Product.
• Managing the QP and Regulatory group, including batch release, product performance, new products introduction (NPI) and regulatory support
• Ensuring that products manufactured on site meet requirements of end users, Regulatory Authorities and of the company
• Ensure the batch and its manufacture complies with the provisions of the marketing authorisation
• Ensure manufacture has been carried out in accordance with Good Manufacturing Practice
• Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records
• Ensure any deviations 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
• Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
• Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so
• Responsible for oversight of product performance process
• Ensure compliance with Quality Risk Management processes and procedures
• Liaising with Global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies
• Ensure effective transfer of NPIs to site and its progress into commercial manufacturing.
• Third level qualification in a science discipline with minimum 5 years’ 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
• Minimum 5 years industrial experience gained in a FDA and EMA approved pharmaceutical environment.
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252