QA Specialist - CSV & Automation (m/f/d)
Responsibilities
- Ensure qualification and validation plans for equipment, infrastructure, and computerized systems comply with Lonza Quality policies
- Review and approve SOPs, commissioning/qualification/validation protocols, reports, and CQV/CSV documentation (e.g., URS, FAT/SAT)
- Provide QA leadership and guidance on qualification/validation topics for large-scale CAPEX projects
- Act as primary QA contact for lifecycle compliance of equipment and computerized systems, including documentation in global systems (Kneat, Trackwise, DMS, Unifier)
- Oversee vendor qualification and ensure adherence to GMP standards
- Manage quality deviations, changes, and CAPAs, ensuring timely resolution and escalation when necessary
- Support project teams during design, commissioning, and qualification phases for aseptic fill-finish facilities
- Collaborate cross-functionally to maintain compliance throughout project execution
- Contribute to continuous improvement initiatives in QA processes and systems
- Ensure compliance with regulatory requirements and internal quality standards
Profile
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field
- Significant experience in GMP-regulated pharmaceutical environments, preferably within a Quality Unit
- Proven expertise in QA for CSV and automation of GMP systems, especially aseptic fill-finish processes
- Strong knowledge of equipment and utilities such as filling lines, lyophilization, clean utilities, and cleanroom facilities
- Familiarity with global QA systems (e.g., Kneat, Trackwise, DMS, Unifier)
- Ability to interpret and approve technical documentation (URS, FAT/SAT, protocols)
- Excellent problem-solving and decision-making skills in a regulated environment
- Fluent in English; German language skills are an advantage
- Strong communication and stakeholder management abilities
- Ability to work independently and lead QA activities for complex projects
Benefits
- Opportunity to work on high-impact CAPEX projects in a global pharmaceutical leader
- Collaborative and innovative work environment with cross-functional teams
- Exposure to cutting-edge technologies and GMP compliance practices
- Inclusive and diverse workplace culture
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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