Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Associate QLCM (m/f)
YOUR TASKS AND RESPONSIBILITIES
· Independently conceive, initiate and provide in a timely mannertechnical registration documentsfor worldwide submission with the aim of maintainingmarketing authorizationand ensuring compliance with the current scientific state
· Design, coordinate and implement complex, globalvariations to regulatory specifications and testingstandards for drugproducts and definition of global quality standards to ensure product quality
· Independently conceive, develop and validate modern analytical methods for release and stability tests of market products as well as their transfer to other Bayer sites and third parties
· Answeringof deficiency lettersfrom international authorities regarding quality specifications, testprocedures and the associated method validations as well ascompilation ofexpert reports
· Evaluate, revise and prepare product monographs of various international pharmacopoeias (e. g.USP and JP)
· Be technically responsible for assigned laboratory technicians as well as for GxP-compliant organization and implementation of all processes in the analytical development laboratory
· Lead site expert and contact person for internal and cross-location functions
· Represent the direct supervisor in cross-divisional and cross-location project teams
WHO YOU ARE
· University degree as licensed pharmacist (m/f), preferably with a PhD
· Several years of professional experience in pharmaceutical analytics as well as extensive pharmaceutical and regulatory knowledge in an international environment
· Profound knowledge in the field of development and validation of qualitative and quantitative analytical methods, especially HPLC
· Confident in its dealingof contents and requirements of international pharmacopoeias as well as ICH and GxP guidelines
· Ability to work independently, accurately, conscientious and in a timely manner
· Exceptional analytical capacity
· Strong team and communication skills for working in a global working environment
· Creativity and the ability to involve and convince people as well as high willingness to perform
· Very good command of written and spoken German and English
This is a fixed-termed contract for 2 years.
The time limit does not apply if the position is filled by an internal permanent employee.
Please use only the internal job board via myServices for your application.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 25060