Computer System Validation Specialist

Description

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 IT Quality and Validation Manager, the CSV Specialist will maintain the validated state of global IT systems (e.g.: SAP, TrackWise, Veeva and EDMS) according to applicable regulations (e.g.: GxP, SarbOx,…). Will comply with cGMP as meant by CFR part 11, EU GMPs Annex 11, and where appropriate GAMP as defined in Centrient policies and ISOPs. Ensure embedding of Quality and Validation in the total Centrient IT approach, thinking and acting. Coach and train direct colleagues as well as Key-Users. Defines IT Quality system and validation methodology​, Organizes quality oversight of IT activities with QA, Monitors IT Risks and ensures Compliance​, Is the key contact for auditors.

The main activities and responsibilities:

• Maintains IT GxP 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 like QA, Finance, etc.
• Acts as System Matter Expert on IT Quality and Validation.
• Coordinate the Yearly Reviews on validated/qualified systems.
• Manages validation projects.
• Performs activities that contribute to the validated state of the systems that are in scope of validation such as change control, testing and organization of test sessions, investigations and preparation/execution of validation protocols and reports.
• Timely escalating problems in the approval process and setting up.

Requirements

The Ideal Candidate:

• Degree in Life Sciences, Computer Science or related fields.
• Minimum of 3’ experience with enterprise systems in a regulated environment
• Experience with Application Lifecycle Management Systems is desirable.
• Fluent in English language (written and spoken).
• Strong knowledge of GxP regulations, ideally in the field of computer system validation.
• Good knowledge of cGxP and GDPR requirements.
• Deep expertise in Computer System Validation for the Pharmaceutical industry.
• Knowledge in the IT and telecommunications domain.
• Strong Quality and continuous improvement mindset.
• Strong communications skills. Communicates effectively with a diverse audience.
• Independent and reliable worker.
• 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.