Expert Data Integrity - (m/f/d) - 12-month Fixed-term Contract

For our client in Aubonne, we are currently seeking a Data Integrity Expert for a 12-month period.

Your role

• Actively lead the upgrade and maintenance of the Data Integrity topic within the Biotech department
• Lead, coordinate and participate in audit trail reviews, access reviews and recipe backups
• Coordinate equipment timing update actions
• Write and coordinate the recording and review of SISA forms for the Biotech department
• Lead the implementation of governance on the management and monitoring of EMS
• Participate in drafting URS for new equipment ensuring compatibility with a modern approach to equipment Data Integrity
• Be the Administrator of automated GMP Process equipment
• Conduct technological watch to raise the standard of Data Integrity in the Biotech department
• Prepare, maintain and review procedures and/or other documents necessary to maintain GMP status of activities performed in their field upon management request
• Responsible for writing protocols and/or reports within their area of expertise
• Be responsible for successfully carrying out technical and/or improvement projects in the Biotech department

Your profile

• Engineering degree or equivalent training.
• Extensive experience with GMP regulations and qualification/validation requirements of computerized systems (CSV).
• Strong knowledge of data integrity, quality systems and pharmaceutical environment.
• Knowledge of production equipment, GMP automated systems and an ERP tool; experience in classified areas is an advantage.
• Fluent French and very good level of English, both written and spoken.
• Determined, forward-looking and results-oriented personality, innovative, collaborative and empowering, with excellent communication skills and good problem-solving and project management abilities.