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Global QA CSQ SME
hace 4 meses
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 Barcelona team for the following position:
The Position
Reporting to the Global QA Director CSV and Data Integrity, providing governance and services to Global IT and supporting the global audit programme. Ensure global GMP applications (SAP, Trackwise, Master Control, Veeva and Infrastructure) compliance with CSV and Data Integrity best practice according to applicable regulations and Corporate Policy and Procedure.
Work with partners in Global IT to ensure that new projects and changes are executed to maintain the validated state.
Apply GMP & cGMP as meant by 21 CFR part 11, EU GMPs Annex 11, GAMP and current eDI best practice. Ensure embedding of Quality and Validation in the total approach, thinking and acting. Coach and train direct colleagues as well as Key-Users. Audit CSV and eDI for Local Sites, System Vendors, CMO, CLO and Global IT.
The main activities and responsibilities:
- Provide QA governance to CSV and eDI practices for Global GMP systems.
- Proactively participate in Global IT projects (new systems and changes).
- Proactively participate in Global IT quality improvement projects.
- Ensure Change Control governance in line with processes and stakeholders such as Local site QA, IT and respective Business Owners.
- 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 Centrient sites and business units and Qualified Vendors.
- Participate in relevant teams for all CSQ and core business process projects to ensure that the necessary validation activities are identified and carried out.
- Participate and provide leadership and technical SME to Global CSV and DI improvement projects.
- Participate in Corporate Audit (Virtual and On site) and for Computerized System.
- Provide IT CSV support for agency audits including multiple international agencies at one time.
Requirements
The Ideal Candidate:
- University degree in technical, science, chemical engineering or computer sciences.
- Minimum of 5 - 8 years’ experience within CSV / DI and Pharmaceuticals.
- Fluent in English language (written and spoken).
- Working knowledge of Global IT systems (SAP, Document Management System, CAPA Management Systems).
- Deep expertise in Computer System Validation and Data Integrity for the Pharmaceutical industry.
- Good Knowledge of GxP Analysis, Gap Assessment, Riskj Assessment.
- Good Knowledge of 21 CFR Part 11, CSV – GAMP and electronic Data Integrity
- 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
Please submit your application via the 'apply' button and upload your CV & cover letter in English. We also ask you to include information on your current remuneration. Only applications with CV and Cover Letter will be considered.
For more detailed information about the role and about the Recruitment & Selection process you can contact us via HRSpain@centrient.com We invite you to visit our website www.centrient.com for information about our company.
Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.
