Sr Analyst Compliance
J&J Family of Companies
Johnson & Johnson Innovative Medicine is recruiting for a Compliance Engineer, located in Schaffhausen.
In this position, you will support CM&T organization as part of Therapeutic Development and Supply R&D for parenteral manufacturing and combination products in all compliance aspects for internal production to ensure timely supplies of clinical trial material.
Key Responsibilities:
+ Close cooperation with the production team leaders/coordinators and the compliance function to support day-to-day business.
+ Define and drive implementation of monitoring activities.
+ Establish training requirements for new filling and device assembly lines and support updates of respective SOPs/WIs.
+ Cross functional collaboration with internal and external partners (QA, QC, Site-Engineering and Technical Operations)
+ Assessment and implementation of new technologies with focus on microbiological and sterility assurance
+ Leads improvement efforts within the compliance and production department.
+ Coordination and timely completion of NCs, CAPAs and CoCs within F2P2 in close collaboration with QA.
**Qualifications**
Qualifications
Education:
+ BSc in Pharmaceutical/Biochemical/Chemical or relevant Sciences
+ 2 years experience in fill/finish operations
+ Background in microbiology would be an advantage
Experience and Skills:
Required:
+ Ability to collaborate with cross-functional teams
+ 2 years experience in fill/finish operations
+ Background in microbiology would be an advantage
+ Professional Working Proficiency in German and English
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
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