Qualification & Validation Technician - 6-Month Temporary Assignment - 100%

About the job

Recognised and essential for over 40 years, Multi Personnel is an agency specialising in the provision of administrative staff and executives, temporary and permanent, across numerous economic sectors such as banking, financial companies, multinationals, NGOs, SMEs and local institutions. We are looking to recruit a Qualification & Validation Technician – 6-Month Temporary Assignment – 100%

Assignment:

Qualification/Validation:

• Draft and execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols,
• Participate in the requalification of the new class B cleanroom environment,
• Contribute to the qualification activities of the new aseptic filling line and associated equipment.
• Contribute to the revalidation activities of sterilisation processes.

Validation of computerised and automated systems:

• Draft and execute qualification protocols for computerised systems.
• Verify the regulatory compliance of systems (data integrity, security, audit trail), notably according to 21 CFR Part 11 and Annex 11.

Review qualification/validation results, analyse deviations, document discrepancies and propose CAPA.

Profile:

• Experience in qualification/validation of cleanrooms, sterile manufacturing systems/processes (equipment/sterilisation) in a GMP environment. Experience with barrier technologies (RABS or isolators) and their qualification in a GMP environment is a major asset.
• Degree in qualification/validation or equivalent.
• Essential experience in the pharmaceutical industry and good knowledge of GMP,
• Knowledge of 21CFR Part 11 and experience in CSV,
• Fluency in French and English is mandatory.
• Autonomy, rigour, team spirit, sense of responsibility and proactivity.

Your contact person:

Your contact for this position is Leila. With over 15 years of experience in recruitment, she will be able to support you, advise you and provide answers to all your questions regarding the position. We will only respond to applications whose profile matches the requested description.