Computer Systems Quality Lead

hace 6 meses

Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completo

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 Global Quality department has a vacancy in its manufacturing site in Santa Perpetua de Mogoda for the following position:
The Position
As 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 practice and maintain 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. Define and own local site CSV processes and procedures, monitors CSQ Risks and ensures compliance, reports on risk mitigation plans and compliance to Corporate QA and local site leadership.

**The main activities and responsibilities**:

- Responsible for maintaining and developing the CSQ (CSV & DI) Quality System.
- Responsible for maintining 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.
- Maintains GMP systems in validated status by coordinating validation activities and ensuring timely issuance of validation documents.
- Executes Change Control governance in line with processes and stakeholders such as QA, Engineer, etc.
- Acts as System Subject Matter Expert on systems Quality and Validation.
- Organize trainings on CSQ processes.
- Define and maintain the GMP compliancy audit agenda for the Qualified Vendors.
- Coordinate the Periodic Reviews on GxP systems.
- Participates in projects.
- Owns related local quality improvement projects.
- Lead Data Integrity Project at the site.

**Requirements**:

- University degree in technical, science, chemical engineering or computer sciences.
- Minimum of 8 years’ experience within CSV / DI and Pharmaceuticals.
- Fluent in English language (written and spoken).
- Working knowledge of Manufacturing Process Automation Systems and Laboratory Workstation and Server / Workstation based systems.
- Deep expertise in Computer System Validation and Data Integrity for the Pharmaceutical industry.
- Good Knowledge of GxP Analysis, Gap Assessment and 21 CFR Part 11 of USFDA in validation.
- Good Knowledge of spreadsheet Validation.
- Project Management skills.
- Strong Quality and continuous improvement mindset.
- Strong communications skills. Communicates effectively with a diverse audience.
- Intercultural skills.

**Benefits**:
Terms and reward
We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals. The organization is very flat. You have a lot of freedom and responsibility in an open, direct, and informal atmosphere.
The Procedure
Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.

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