Qualification Specialist
Randstad (Switzerland) Ltd.
Publication date:
11 January 2025Workload:
100%- Place of work:Bulle
job details
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
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qualifications
What will make you successful:
- 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
Laetitia Stirer
- Randstad UCB Bulle
