Qualification Specialist

vor 1 Tag

Bulle, Schweiz Randstad (Schweiz) AG Vollzeit

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
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