Sr. CSV Manager – IT for global Pharma Processes

Contractor - 12 months – French and English

Our client is an international biopharmaceutical company headquartered in the French speaking part of Switzerland with globally established and recognized products in innovative therapeutic areas.

Proficiency into Computer System Validation (CSV) in the pharmaceutical environment is required. You will improveme or fully implementation of off-the-shelf and configurable (Gamp 3 and 4) standalone and interconnected standalones, regulated by the GMP. To a lesser extent, you will collaborate on Gamp 5 worldwide/interconnected systems

Responsibilities:

• IT Requirements, GMP Regulation, must be explained and obtained from the vendor of system. If necessary, customize the system, adapt the process, to comply to GMP.
• Guarantee Data Integrity of the system into its environment and process.
• Design through elicits, analyzes, documents, and validates detailed user / functional / non-functional requirements; identify gaps between system capabilities and requirements to ensure that business needs are met
• Adjust the number of deliverables, their quality and complexity to guarantee the respect of timelines and fit to validation approach
• Assist the translation of compliance requirements into test conditions and expected results for application functionality, and acceptance testing (IQ, OQ, PQ, FAT, SAT)
• Drive development and execution of change management and training throughout the organization during the implementation and ongoing use of system applications.

Your Qualifications & Competencies

• Pharmaceutical, Biotechnology, Life Science industry experience is a must.
• App 5-10 years’ experience IT Engineer running project from requirements to delivery of final product and documentation included
• Familiar with Change Management tools and regulated document authoring
• COTS and Web-based requirements, architecture, Agile/SCRUM methodology
• Proven experience in the installation and qualification of Aveva-PI suites is a strong plus.
• Proven experience in the installation and qualification of Building Automation systems (Desigo, RMS Rotronic) is a strong plus
• Experience in Computer System Validation.
• Awareness of 21-CFR Part 11, Eudralex, MHRA.
• Fully operational in French and English.

We are looking for a personality, autonomous in analysis, problem solving and achieving deliverables. You have shown to have a strong influence of colleagues to positive outcome.