Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Kaiseraugst, we are looking for a

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. This is achieved through maintenance, validation and harmonization of processes (asset lifecycle).

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

Our offer:

• A modern workplace with many social- and green zones
• Fair compensation with 2 days / week home office possibilities
• Familiar motivated team
• The ability to work for a company who works towards creating a positive impact on patients livelihood

If you would like an insight into the detailed job description, we look forward to receiving your complete application documents addressed to Ms Leonie Gysin.

Aargau Vollzeit Fulltime Pharma Qualifizierung Validierung