QA CSV Validation Specialist

Our client, a prominent global organization in the vaccine industry, is seeking a specialist to oversee the validation and qualification of automated and computerized systems. The role ensures the maintenance of a validated status for critical systems through rigorous documentation review and quality assurance oversight.

• Write, review, and approve validation plans and validation summary reports to ensure technical compliance.
• Review and approve design documentation including URS, DQ, ERES, and TCD.
• Oversee the approval of qualification protocols and reports for IQ, OQ, and PQ phases.
• Maintain CSV specific SOPs and templates to ensure alignment with current validation methodologies.
• Manage quality system activities including CAPA, deviations, and change control related to automated systems.
• Support management and technical teams during internal and external regulatory audits.

• You have a Master's degree in Sciences, Biological Engineering, Pharmacy, or a related field.
• You bring experience in a CSV (Computer System Validation) role within a regulated environment.
• You possess knowledge of CGMP and regulations for automated systems such as GAMP, Eudralex Vol 4 Annex 11, and 21 CFR Part 11.
• You have experience with validation practices including ICH guidelines, ASTM E2500, and life cycle approaches.
• You bring proficiency in SAP and MS Office.
• You are analytical, rigorous, and possess a quality-oriented mindset.
• You are fluent in French and English.

Nice to Haves

• Certification in computer system validation.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.