Quality Assurance Manager (f/m/d)

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Patheon Regensburg is a GMP production site, focused on custom manufacturing of investigational materials for pre-clinical and clinical studies. The size of the site offers a familiar, friendly and collegiate atmosphere that specializes in the combined strengths of high-end R&D and production.

For the support of our Team in Regensburg we are looking for a

Quality Assurance Manager (f/m/d)

Discover Impactful Work:

The position of Quality Assurance Manager/DICO (f/m//d) encompasses all activities required to ensure a consistently high quality of all development and synthesis activities as well as the resulting products and documentation. This includes the introduction of all regulations and requirements of the ISO 9001 and GMP quality systems, depending on the development status of a project.

A day in the Life:

• Responsibility in all areas of quality assurance, including Data Integrity Compliance Officer responsibilities
• Implementation and maintenance of quality systems (GMP, ISO 9001) as well as internal quality guidelines
• Support preparation and maintenance of the quality manual, site master file and other compliance-related documents
• Review and approval of quality-relevant documents
• Approval of certificates of analysis and release of products
• Performing and support of internal and external quality audits and inspections
• Responding to audit reports; Implementation of CAPAs in the responsible area
• Review and approval of the calibration of measuring instruments, the suitability or validation of analytical methods and production processes, including the qualification and cleaning of equipment
• Ensuring compliant documentation and archiving of test results, development results and manufacturing documents
• In-house training and oversight of training of employees
• Collaboration with Process R&D, pilot plant and maintenance departments as well as with corporate functions
• Support of supplier qualification
• Support of projects with respect to QA related topics

Keys to Success:

Education

• University degree in chemistry (or related area), ideally with a PhD

Knowledge, Skills, Abilities

• Several years of professional experience or practice in working in regulated environments (cGMP, ISO), ideally in connection with the manufacture of active pharmaceutical ingredients
• Proficiency in English and German (verbal and written)
• Solution and customer orientation, very reliable way of working
• Interpersonal skills, ability to work under pressure and to work in a team

What we offer:

• Employment with an innovative, future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.

Apply today! http://jobs.thermofisher.com

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