GMP Training & Personnel Qualification – Sterile Pharmaceuticals
Company: Antaes Consulting
- Location: Zurich, Switzerland
- Seniority: Mid level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Location: Canton of Zurich – on site
Start date: As soon as possible
Workload: 80–100%
Your mission
On behalf of one of our clients, an FDA- and EU-GMP-certified manufacturer of sterile pharmaceutical products, we are looking for an Interim Manager GMP Training & Personnel Qualification to lead and modernize the site-wide training and qualification framework.
- Own and develop the site GMP training, competency and personnel qualification system
- Define qualification and certification standards, as well as requalification programs, for critical GMP activities in Production, QC and Microbiology
- Build risk-based training curricula, competency assessments and qualification pathways
- Drive the digitalization of training processes and the further development of the LMS
- Act as site subject matter expert for GMP training, in close partnership with Production, Quality, QC, Microbiology and Engineering
- Ensure training effectiveness, qualification compliance and data integrity for audits and inspections
- Foster a culture of competency, accountability and continuous learning supporting sterility assurance
Desired profile
- Degree in Pharmacy, Pharmaceutical Sciences, Microbiology, Biotechnology, Engineering or a related field
- Several years of experience in GMP pharmaceutical manufacturing, including sterile or aseptic operations
- Proven experience in GMP training, personnel qualification or competency management
- Strong knowledge of FDA, EU GMP and Annex 1 requirements
- Experience with LMS, eQMS or similar digital training and quality systems
- Strong stakeholder management skills at all organizational levels
- Fluent English and strong German communication skills
About Antaes:
Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 10 consulting companies in Switzerland. We have over 300 experienced engineers who share our passion.
Present in Switzerland, Singapore, and France, we support both Swiss and international clients in the following areas:
- Organizational and transformation consulting
- Industrial engineering
- Information systems management
By joining our teams, you will discover:
- A dynamic team with a start-up mindset
- Personalized support and career development follow-up
- Opportunities to expand your network through exciting challenges
- Events: team buildings, meet-ups, workshops, Summer Event
- A company certified @HappyAtWork and committed to CSR, awarded Ecovadis Gold Medal 2025
You too can be part of the Antaes adventure :)
We sincerely appreciate the interest of all applicants in our organization. However, only those selected for further consideration will be contacted.
Where applicable, the masculine form is used for readability purposes and is intended to be inclusive of all genders.
