Qualification Specialist

Location: Bulle, SwitzerlandActivity rate : 100%Type of contract: Temporary contractStart Date: 01.02.2025End 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
• HSE policies, report incidents, and promote safety culture

Requirements:

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 kledge 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