Job Title: Quality Control Specialist Location: SwitzerlandLanguage Requirements: Fluent in English; German language skills strongly preferred Employment Type: Contract / Full-timeAbout the RoleCK QLS is seeking an experienced Quality Control Specialist to support our client in the pharmaceutical sector. This role will focus on ensuring compliance with global GMP Quality Systems and regulatory requirements, particularly within biologics and vaccines manufacturing. You will play a critical role in maintaining product quality, overseeing external manufacturing, and supporting regulatory submissions.
Key ResponsibilitiesReview and approve Master Batch Records to ensure conformance with company policies, procedures, and all governing regulationsManage both routine and complex deviationsSupport process and analytical change requestsMaintain retention samples, ship reagents and samples to support licensure and foreign registration, and manage shipments under quarantineSupport routine process validation activities; review and approve validation reports and tech transfer documentationPrepare pre-PAI assessments; support regulatory document requests and post-approval changesConduct regular site visits to external manufacturing partners to build relationships, monitor quality, and drive improvements through structured communication programsRequired Skills & ExperiencePrevious pharmaceutical industry experience with in-depth knowledge of Quality Systems, Quality Assurance, and Quality Control, including global GMP requirementsStrong problem-solving skills with the ability to work independently and take initiativeExperience in managing deviations and supporting validation activitiesExcellent interpersonal, leadership, and cross-functional collaboration skillsAbility to work across organisational boundaries and act as a subject matter expert when neededFluent in English; German language proficiency strongly preferredDegree in Science, Engineering, or relevant technical discipline (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, etc.
) preferredPreferred (Nice to Have)Experience managing external manufacturing partnersBackground in manufacturing operations and/or analytical expertise in biologics and/or vaccinesPrevious involvement in regulatory communications (e. g. , BLAs, NDAs)To apply please reach out to Rob Angrave at CK QLS. Please quote 147957 in all communications All applicants must have full working right for Switzerland to be considered.
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