Senior Manager, Product QA

Fastnet The Talent Group

Sligo

Our Client are currently looking for a Senior Manager, Product QA to lead and coach our diverse, 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. As a key strategic site for new product introduction within our manufacturing network, the successful candidate will be integral to the effective transfer of NPIs to our site. This will include significant involvement in Pre-Authorisation Inspections from regulatory authorities including the HPRA/EMA and FDA. You will also be responsible for product performance, managing the product complaints. Responsibilities: Managing the QP and Regulatory group, including batch release, product performance, new products introduction (NPI) and regulatory support. Ensuring that products manufactured at 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. Should in addition take into account any other factors of which they are aware which are relevant to the quality of the batch. Should maintain their knowledge and experience 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. Ensure that all QPs have gained the relevant knowledge and experience to certify a batch of a product type with which they are unfamiliar, for example because a new product range has been introduced, prior to certification. Ensuring compliance with the requirements of during the manufacturing process. Responsibility for the oversight of product performance process. Product Quality Review. Complaints. Product Track and Trend. Ensure effective transfer of NPIs to site and its progress into commercial manufacturing. Coordinate with external global teams including, but not limited to S&T, Regulatory, CMC QA. Requirements BSc with 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. Must have 3 years Supervisory/Management experience. Excellent communication skills. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2186 days ago