The scope of this activity includes Pharmaceutical process equipment and HVAC/Clean Room/Process.

Your main tasks will be (not exhaustive list) to:

• Ensure that Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities,

• Ensure that Qualification Master Plans are up to date and established for all ongoing projects,

• Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to Qualifications Plans, FMEA, IQOQPQ,

• Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master Plans, Qualification documentation, etc.),

• Operational handling of Changes Controls, CAPAs and Non-Conformances related to qualification topics.

PROFILE

• You have a degree in Life Science s, engineering or equivalent by experience.

• You have at least 2 years of experience in Qualificationin the Life Sciences Industry.

• You are used to work in regulatory environment and have strong knowledge of regulatory standards related to pharmaceutical or biotechnology environment (GMP, GLP, ICH, 21 CFR, etc.).

• You speak fluently French and English.

• You have strong communication skills and an analytical thinking.