QA operations manager
Posted on Sep 8, 2020 by Real Staffing Group
You will have the opportunity to join an exciting expansion project in a start up facility, and will be part of the decision making in building and coaching an expert quality team. You will lead the product life cycle, and requires a strong leader to partner closely with the senior leadership team and will be involved in a number of global projects.
. Have say on recruitment of the team, and lead the team in batch release, product performance, data analytics, and NPI.
. You will be the delegate to the Quality Director
. Support the effective transfer of NPIs to site and into commercial manufacturing; coordinating with external global teams
. Ensure product manufacture is in accordance with Good Manufacturing Practice and meets requirements of our patients, Regulatory Authorities (FDA, HPRA etc.) and of the company
. Partner with internal and external Regulatory groups, FDA, HPRA etc. while liaising with operations, technical operations, science & technology teams in relation to product filing support.
. Have responsibility for the oversight of product performance process, product quality Review, complaints and product track and trend
. Ensure compliance with all processes and procedures while maintaining the Quality Risk Management (QRM) program on site
Education & Experience:
. Third level qualification in a relevant science discipline with minimum 5 years' experience in the pharmaceutical industry
. Minimum 5 years industrial experience gained in an FDA and EMA approved pharmaceutical environment.
. Minimum 3 years' experience in an aseptic sterile fill finish manufacturing environment an advantage
. People Management experience is required
Please note you must have a valid EU passport or stamp 4 visa to apply for this role
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales