For one of our Clients, a company based in Kaiseraugst, we are looking for a Qualification Expert.
The perfect candidate is an experienced qualification expert with several years of hands-on experience in qualification within a GMP environment, preferably the pharmaceutical industry.
General Information:
- Start date: ASAP
- Planned duration: 12 months
- Extension: possible
- Workplace: Kaiseraugst
- Workload: 100%
- Remote/Home Office: max. 20%
- Travel: no
- Team: 10 people
- Working hours: Standard
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 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 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 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-organised teams and for your own areas of responsibility areas of responsibility with a focus on the big picture
For one of our Clients, a company based in Kaiseraugst, we are looking for a Qualification Expert.
The perfect candidate is an experienced qualification expert with several years of hands-on experience in qualification within a GMP environment, preferably the pharmaceutical industry.
General Information:
- Start date: ASAP
- Planned duration: 12 months
- Extension: possible
- Workplace: Kaiseraugst
- Workload: 100%
- Remote/Home Office: max. 20%
- Travel: no
- Team: 10 people
- Working hours: Standard
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 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 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 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-organised teams and for your own areas of responsibility areas of responsibility with a focus on the big picture
