Senior Manager QA

Collins Mcnicholas Recruitment

Sligo

Our client, a leading pharmaceutical company in Sligo, is looking to hire a Senior QA Product Manager. Responsibilities: Managing the QP and Regulatory group, including batch release, product performance, new products introduction (NPI) and regulatory support. Ensuring that products manufactured 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 all requirements of during the manufacturing process. Maintain QRM program on site. Liaising with Global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies (where applicable. 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: 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. For a confidential discussion please contact Mark Whelan on 071 914 2411 or emailmark.whelan@collinsmcnicholas.ie, For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our websitewww.collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.

2137 days ago