Qualification Expert
vor 1 Woche
Qualification Expert (M/F/d)
Qualification Expert (M/F/d) - GMP /
COMOS / EVAL / German / English
Project:
For our customer a big pharmaceutical company based in Kaiseraugst we are looking for a highly qualified Qualification Expert (M/F/d)
Background:
The support function ES&T (Engineering, Science and Technology) supports the value streams (production) with its technical expertise and ensures the regulatory requirements for our products over the entire life cycle.
Tasks & Responsibilities:
- Responsible for planning and conducting qualification and validation activities
- Creating and reviewing qualification and validation documents
- Producing SOPs and providing support in the creation of manufacturing specifications
- Responsible for maintaining the qualified and validated status of rooms, infrastructure and equipment
- Ensuring compliance with internal and external regulatory requirements with regard to qualification and validation
- Collaborating closely and communicating intensively with other departments
- Providing assistance in the processing of deviations, changes and CAPAs
Must Haves:
- Technical degree or relevant work experience in qualification with GMP
- Further training and handson experience in the area of GMP* Min. 35 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
- Several years hands on work experience in qualification is a MUST
- Experience with Siemens COMOS, EVAL and VIVA is a plus
- Fluency in German spoken and written needed, English fluency written and reading comprehension
- Very independent and structured way of working with a selfimage of self and to continuously improve the processes
- High degree of initiative, flexibility and quick comprehension skills
- Enthusiasm for working together in selforganised teams and for your own areas of responsibility areas of responsibility with a focus on the big picture
Reference Nr
:
Role:
Qualification Expert (M/F/d)
Industrie:
Pharma
Workplace:
Kaiseraugst
Pensum: 100%
Start:
Duration: 12++
Deadline:
Job Type:
100%
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