Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients, and finished dosage forms. We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our commitment to Quality, Reliability, and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers' needs. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance. Founded 150 years ago as the 'Nederlandsche Gist- en Spiritusfabriek', our company was known as Gist Brocades.
Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States, and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.
The PositionAs a Computer Systems Quality Site Lead (M/F/d), you will be part of the Global Quality department reporting directly to the Corporate Computer System Validation Manager. You will be responsible for ensuring compliance with Data Integrity best practices and maintaining the validated state of local GxP systems (DCS/ PLC / SCADA / Empower / Analytical Instrument Workstations) according to applicable regulations and Corporate Policy and Procedure. Comply with cGMP as meant by CFR part 11, EU GMPs Annex 11. Ensure embedding of Quality and Validation in the total site approach, thinking, and acting. Coach and train direct colleagues as well as Key-Users.
ResponsibilitiesResponsible for maintaining and developing the CSQ (CSV & DI) Quality System.Responsible for maintaining and developing CSV, Quality Management System Framework; this includes responsibility to:Develop/refresh of CSV-related SOPs, Guidelines, Standards, Templates, and Training materials to the agreed timescales for Global Compliance.Conduct in-depth monitoring reviews, provide assurance that business controls align with regulatory requirements and implement effective regulatory risk control.Maintain GMP systems in validated status by coordinating validation activities and ensuring timely issuance of validation documents.Execute Change Control governance in line with processes and stakeholders such as QA, Engineer, etc.Act as System Subject Matter Expert on systems Quality and Validation.Organize trainings on CSQ processes.Define and maintain the GMP compliance audit agenda for the Qualified Vendors.Coordinate the Periodic Reviews on GxP systems.Participate in projects.Own related local quality improvement projects.Lead Data Integrity Project at the site.
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