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For our client, a leading pharmaceutical company in Switzerland, we are looking for a Qualification and Validation Manager.
General Information:
* Duration: until 31.10.2025
* Workplace: Basel
* Remote/home office: No
* Team: 10 people
* Working hours: Standard
About the job:
For our client, quality is at the core — a competitive advantage and a shared responsibility of all employees, from concept to continuous improvement, for the well-being of every patient.
The Qualification Manager is responsible for the CSV and qualification program at Basel DS Manufacturing, as well as activities to maintain qualified status in collaboration with the engineering and operators at Basel Drug Substance Manufacturing (for biochemical and chemical manufacturing processes).
Your profile:
The ideal candidate holds a master's degree in chemical engineering and more than 2 years of experience in a pharmaceutical GMP environment. Furthermore, the person is familiar with the qualification and validation of pharmaceutical production facilities and equipment. Finally, the person possesses good IT skills and excellent German and English language skills.
Tasks & Responsibilities:
* Management and coordination of CSV and qualification projects Review and approval of qualification plans and reports
* Creation of qualification strategies, risk analyses, qualification plans and reports
* Assessment of qualification reviews
* Coordination of cooperation with the production and support departments
* Collaboration and management of specific GMP projects as required or as assigned, as well as in the implementation of cross-departmental and internal GMP concepts
* Maintenance of the quality system
* Ensuring data integrity in computerized systems
* Knowledge of and compliance with all programs, procedures and instructions relating to SGU
* Reporting of unsafe working conditions and actions
* Review and approval of CA lists
* Coordination and documentation of global change requests
* Deviation management in Trackwise
* Creation of GMP documents: SOPs and validation documents
* Development and application of suitable tools for managing and monitoring the entrusted projects
* Development and implementation of suggestions for improvements to the plant and equipment qualification concepts
* Management and coordination of risk analyses (QRM - Quality Risk Management)
* Authority and customer audits: Supporting companies during audits. Assistance in implementing measures
* Self-inspections: Accompanying audits. Assistance in implementing measures
* Problem prevention: Always keeping quality in focus when carrying out daily work. Identifies problem areas and develops solutions to avoid them
Must Haves:
* Master's degree in chemical engineering, biotechnology, similar discipline or chemical engineer
* At least 2 years of solid experience in the cGMP environment relevant to the pharmaceutical industry
* You are also familiar with the operation and qualification / validation of pharmaceutical production plants and equipment
* Very good written and spoken German and English skills
* MS Office, Gsuite, Visio, Lucid Chart knowledge
* Good interaction with stakeholders
* Team player
* Sense of urgency
Nice to haves:
* Veeva and eVal experience
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
Application Submission Deadline: 15.06.2025
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Contract
Job function
* Job function
Other
* Industries
Pharmaceutical Manufacturing
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