Qualification-Validation pharmaceutical equipments F/M/X

Mission Description

We are looking for a Qualification and Validation Specialist for pharmaceutical equipments.

• Start date: ASAP
• Mission duration: 3 months, renewable
• Type of mission: Acting as a Qualification Specialist on various qualification projects during the shutdown.
• Non-exhaustive list of equipment/systems: Freezers/refrigerators, laboratory equipment, clean utilities (water and gases), classified areas, etc.

Qualification Specialist

Skills and Knowledge required :

• Minimum 5 years of confirmed experience in Equipment Qualification/Validation
• Mastery of activities related to the V-cycle
• Knowledge of other qualification methods is a plus (e.g., C&Q, ASTM E2500)
• Experience in clean utilities (Water for injection, purified water, clean steam) is a plus
• Confirmed experience in writing, executing, and reviewing qualification protocols and reports, as well as technical documents
• Experience in conducting Risk Analysis (e.g., FMEA)
• Experience in Root Cause Investigation (e.g., Fishbone/Ishikawa/6M, 5 Whys)
• Experience working in a GMP environment
• Mastery of regulatory requirements related to qualification/validation (particularly but not exclusively: EU GMP, 21 CFR)
• Customer-oriented (internal and external)
• Ability to deliver within deadlines, activity reporting, and proactivity in managing and resolving common issues related to the role
• Proactivity, autonomy, honesty, integrity, team-player
• French and English mandatory

Responsibilities & tasks:

• Writing, reviewing, executing, approving technical documents such as Risk Assessment, URS, DQ, FDS (non-exhaustive list)
• Writing, reviewing, executing, approving validation protocols, reports (FAT/SAT, IQ, OQ, PQ)
• Continuous improvement based on technology, regulations, and/or company needs
• Writing, reviewing, approving SOPs and documents related to qualification activities
• Management of CAPA, Deviation, Change Control, and any other quality systems related to qualification activities
• Support during customer and regulatory audits
• Provides reliable support to internal and external clients to ensure timely completion of activities/projects while ensuring satisfactory quality level

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.