Qualification Expert
vor 2 Wochen
About the Role
We are seeking a highly skilled Qualification Expert to join our Business Acceleration team in Bulle, Switzerland.
As a Regulatory Compliance Specialist, you will be responsible for ensuring the qualification of installations and systems in line with procedures, regulatory requirements, and user needs.
You will provide expertise in qualification during investigations, Change Controls, and projects, and present the qualification process and documentation during inspections and audits by health authorities and partners.
Responsibilities
- Develop and execute qualification strategies.
- Lead risk assessments and prepare qualification documents.
- Ensure proper qualification of GMP installations and utilities.
- Coordinate with external partners and maintain schedules.
- Perform periodic requalification and update necessary files.
Requirements
- BS in Engineering, Science, or equivalent technical degree.
- In-depth knowledge of commissioning and qualification activities, including risk analysis expertise.
- 5 years in pharmaceutical and/or biotechnological manufacturing.
- 5 years in qualification of equipment in controlled areas.
- In-depth knowledge of cGMPs and regulations linked with biotech/pharmaceutical manufacturing.
- Strong organizational skills.
- Excellent communication skills, for communicating with internal and external partners, with a good level of spoken and written French and English (B2 minimum).
What We Offer
As a member of our Business Acceleration team, you will have the opportunity to work with a collaborative team of internal and external colleagues, and contribute to the development of our qualification processes and documentation.
Apply Now
If you are a motivated and experienced professional looking to make a meaningful contribution to our team, please submit your application.
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