Qualification Expert (m/f/d)

job details

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     
• Latest Start Date: 01.08.2024
• 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     
• Latest Start Date: 01.08.2024
• 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