Project:
For our customer, a big pharmaceutical company in Kaiseraugst, we are looking for a highly qualified Qualification Expert.
Background and perfect candidate:
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. This is achieved through maintenance, validation, and harmonization of processes (asset lifecycle).
The perfect candidate is an experienced qualification expert with several years of hands-on experience in qualification within a GMP environment, preferably in the pharmaceutical industry.
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 regarding 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 in a relevant field
* Further training and hands-on experience in the area of GMP
* Min. 3-5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
* Several years of hands-on work experience in qualification
* Experience with Siemens COMOS, EVAL, and VIVA
* Fluency in German spoken and written; English fluency in written and reading comprehension
* Very independent and structured way of working with a self-image of self and to continuously improve the processes
* High degree of initiative, flexibility, and quick comprehension skills
* Enthusiasm for working together in self-organized teams and for one's own areas of responsibility with a focus on the big picture
Reference Nr.: 923806SGR
Role: Qualification Expert
Industry: Pharma
Workplace: Kaiseraugst
Pensum: 100%
Start: ASAP
Duration: 12++
Deadline: 19.11.2024
Job Type: 100%
Schedule:
* 8 Hour Shift
Work Location: On the road
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