Quality Control Specialist

Job Title: Quality Control Specialist

Location: Switzerland

Language Requirements: Fluent in English; German language skills strongly preferred (Master Batch Record reviews in German)

Employment Type: Contract / Full-time

About the Role
CK 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 Responsibilities

• Review and approve Master Batch Records to ensure conformance with company policies, procedures, and all governing regulations.
  
  
• Manage both routine and complex deviations.
  
  
• Support process and analytical change requests.
  
  
• Maintain retention samples, ship reagents and samples to support licensure and foreign registration, and manage shipments under quarantine.
  
  
• Support routine process validation activities; review and approve validation reports and tech transfer documentation.
  
  
• Prepare pre-PAI assessments; support regulatory document requests and post-approval changes.
  
  
• Conduct regular site visits to external manufacturing partners to build relationships, monitor quality, and drive improvements through structured communication programs.
  
  

Required Skills & Experience

• Previous pharmaceutical industry experience with in-depth knowledge of Quality Systems, Quality Assurance, and Quality Control, including global GMP requirements.
  
  
• Strong problem-solving skills with the ability to work independently and take initiative.
  
  
• Experience in managing deviations and supporting validation activities.
  
  
• Excellent interpersonal, leadership, and cross-functional collaboration skills.
  
  
• Ability to work across organisational boundaries and act as a subject matter expert when needed.
  
  
• Fluent in English; German language proficiency strongly preferred.
  
  
• Degree in Science, Engineering, or relevant technical discipline (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, etc.) preferred.
  
  

Preferred (Nice to Have)

• Experience managing external manufacturing partners.
  
  
• Background in manufacturing operations and/or analytical expertise in biologics and/or vaccines.
  
  
• Previous 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.