QA operations manager

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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.You will:

* 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

Qualifications

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 rolePlease click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales