Job Title: Computer System Validation (CSV) Lead
The Computer System Validation (CSV) Lead plays a crucial role in ensuring compliance with regulatory requirements by validating computer systems within the pharmaceutical industry. This position encompasses the planning, coordination, and execution of validation activities for software and computerized systems utilized in drug manufacturing, laboratory operations, and quality management.
Key Responsibilities:
- Develop and implement validation strategies in accordance with regulatory guidelines (e.g., FDA, EMA, GxP).
- Create and maintain comprehensive validation documentation including Validation Master Plans, User Requirements Specifications, Risk Assessments, and Protocols.
- Lead validation activities encompassing IQ/OQ/PQ phases.
- Conduct thorough risk assessments and impact analyses for validation projects.
- Manage project timelines, resources, and budgets effectively.
- Communicate project status and issues clearly with stakeholders.
- Participate in audits and inspections.
- Develop and conduct training sessions focused on CSV.
Requirements:
- University degree or equivalent in Business Administration, Information Technology, or Technical Engineering.
- 5-8 years of professional experience in IT Computer System Validation (CSV) / IT Quality Management.
- Relevant project/service IT management experience with a strong understanding of IT standards.
- Experience in IT environments within the healthcare industry (GxP, CSV); specific experience in manufacturing is a significant advantage.
- Strong team player with assertiveness and exceptional communication skills.
- Proficiency in English and German is required; other languages are a plus.
Offering:
- Consultancy services for international clients in a dynamic, growing market with strategically relevant projects.
- A professional consultancy environment within a highly motivated team.
- Ownership in shaping and defining new products within our service portfolio.
- Promising opportunities for personal development within a growing company, including potential leadership roles.
Benefits:
- Paid internet at home.
- Public transport expenses covered.
Onsite presence in Basel is required at 100%. Apply online using the form below. Only applications matching the job profile will be considered.