Senior Product QA Manager

Sigmar Recruitment

Sligo

Purpose. You will lead and coach the diverse, technical team of 6 experienced Quality and Regulatory professionals, including 3 QPs. You will be responsible for the release of all finished products from the site across API and Drug Product, ensuring that they meet the requirements of patients, Regulatory Authorities and the company. You will also be responsible for product performance, managing the product complaints. We will be looking for a key Quality Talent to help us to maintain the very strong compliance reputation that we have gained through multiple PAI inspections over the last number of years. The strong pipeline of products in this company means that they we are continuously expanding and therefore always looking for new talent who can develop and grow with them. Requirements. You will have a MSc in Industrial Pharmaceutical Science or similar course recognised by the Regulatory Authority to permit QP. You will have 5+ years’ experience in the pharmaceutical industry in an FDA and EMA approved environment. Responsibilities. You will be managing the QP and Regulatory group, including batch release, product performance, new products introduction and regulatory support. You will be working with the QA Director, Quality Control and Quality Systems group to ensure the site meets its customer, quality service, regulatory and financial goals. You will be responsible for the oversight of product performance process. You will be accountable for ensuring compliance with Quality Risk Management processes and procedures. To apply for this position please contact Amanda Reynolds at Sigmar RecruitmentT: +353 91 455304 E:areynolds@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. This job originally appeared on RecruitIreland.com.

2173 days ago