Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start Date: 01.02.2025
End Date: 31.12.2025 (with a potential extension)
Are you passionate about ensuring the reliability and compliance of equipment in the pharmaceutical industry? We're looking for a meticulous Qualification Specialist to take the lead in qualifying GMP installations, equipment, and utilities.
Key responsibilities:
- Define the global qualification strategy
- Lead and write qualification risk assessments
- Write qualification plans, protocols and reports
- Ensure the correct qualification of GMP installations (including equipment, software, logic controllers and utilities)
- Maintain and update the planning of qualification activities
- Ensure the coordination of qualification activities with external partners
- Perform the periodic requalification of utilities in collaboration with authorized external subcontractors
- Write and update the QMF (Qualification Master File) and PQR (Product Quality Review) documents
- Improve qualification processes and documentation
- Ensure adherence to project timelines and lead qualification projects
- Act as SME in cross-functional and qualification-related initiatives
- Comply with cGMP standards and maintain accurate documentation
- Provide SME input on deviations, Change Controls, and audits
- Apply HSE policies, report incidents, and promote safety culture
Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start Date: 01.02.2025
End Date: 31.12.2025 (with a potential extension)
Are you passionate about ensuring the reliability and compliance of equipment in the pharmaceutical industry? We're looking for a meticulous Qualification Specialist to take the lead in qualifying GMP installations, equipment, and utilities.
Key responsibilities:
- Define the global qualification strategy
- Lead and write qualification risk assessments
- Write qualification plans, protocols and reports
- Ensure the correct qualification of GMP installations (including equipment, software, logic controllers and utilities)
- Maintain and update the planning of qualification activities
- Ensure the coordination of qualification activities with external partners
- Perform the periodic requalification of utilities in collaboration with authorized external subcontractors
- Write and update the QMF (Qualification Master File) and PQR (Product Quality Review) documents
- Improve qualification processes and documentation
- Ensure adherence to project timelines and lead qualification projects
- Act as SME in cross-functional and qualification-related initiatives
- Comply with cGMP standards and maintain accurate documentation
- Provide SME input on deviations, Change Controls, and audits
- Apply HSE policies, report incidents, and promote safety culture
