Jobdescription 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 Qualifikationen 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