CSV Consultant

On behalf of one of our pharmaceutical clients at RED , We are looking for an experienced CSV & QA Specialist to support a strategic digital transformation initiative aimed at implementing and validating several GxP-critical systems across manufacturing operations.

Job Role - CSV Consultant

Start - ASAP

Duration - 6 months + extensions

Location - France Hybrid Working

Job Requirements -

• 8+ years of experience in Computerized System Validation (CSV), preferably within highly regulated environments such as pharmaceutical or life sciences.
• Proven experience supporting and/or leading validation activities for systems such as MES, WMS, AVEVA System Platform, LIMS, or other GxP-regulated computerized systems.
• Strong knowledge and practical experience with relevant regulatory and industry standards, including:
• GAMP 5
• EU GMP Annex 11
• 21 CFR Part 11
• Data Integrity requirements and principles
• Excellent written and spoken English, with the ability to communicate effectively in an international and multicultural environment.
• Ability to work independently while collaborating effectively with multidisciplinary project teams.
• Strong organizational, communication, coordination, and stakeholder management skills.
• Experience working within complex digital transformation or manufacturing IT programs is highly desirable.