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ALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.
With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.
We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.
Learn more about us on our webpage : www.altogen.ch
About the job :
Executing and managing cleaning validation activities and change management activities to meet GMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations.
Main responsibilities:
- Support site validation planning by writing and maintaining master plans for cleaning processes and ongoing cleaning.
- Author and review cleaning validation protocols & reports, ongoing cleaning verification protocols & reports.
- Support execution of cleaning validation activities at the shop floor.
- Reviews Cleaning Master Batch Records and associated change controls. Confirm revalidation need based on technical changes.
- Maintain all activities and projects under own responsibility in an inspection ready status.
- Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
- Ensure that all site validation activities are performed and are coordinated with cGMP requirement, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
About you:
- BSc.in Pharmacy, Chemistry, Chemical / Pharma Engineering, or equivalent.
- Fluent in English and in German.
- Preferably 2-3 year experience in manufacturing/ manufacturing science and technology/technical development/quality.
- Understanding of manufacturing processes and related process equipment.
- Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
- Experience in executing process validation.
- Expert in reviewing and writing technical reports.
What we offer:
- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirit and an integration within the "Tribe"
Job Type: Permanent
Work Location: In person
