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
Qualifications:
An Engineering diploma (Preferably in life science)
Over 3 years of experience in pharmaceutical and/or biotech manufacturing, including work in controlled areas
Proven expertise in qualification of installations and systems, with in-depth knowledge of cGMPs and related regulations
Experience in leading qualification strategies and defining qualification plans
Strong planning, organizational, and problem-solving skills, with the ability to work autonomously
Excellent communication skills and a collaborative mindset, with a solution-oriented and pragmatic approach
Proficient in MS Office tools and basic statistics
Fluent in French and English, spoken and written
Contact: Laetitia Stirer
Randstad UCB Bulle
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