Senior Specialist (m/f/d) Quality Assurance Europe in der Städteregion Aachen
West Pharmaceutical Services Deutschland GmbH &Co. KG - Vollzeitbeschäftigung
Start ab sofort - Online seit dem 15.04.2019
Welcome to West!
Established in 1923, West Pharmaceutical Services, Inc. has become a global leader in innovative solutions for injectable drug administration. Eachevery day, West manufactures more than 112 million products that are used to help improve health care for millions of people around the world. our team of 7,500 employees in 16 countries to help us write the next chapter of our success story. We are constantly looking for new talentspeople who won’t settle for second best. Thinkers. Doers. Enthusiasts. As an employee, you will experience a collaborativedynamic global working environment,your development is our priority.
At the earliest possible date, we are looking for a motivated Senior Specialist (m/f/d) Quality Assurance Europe for our location Eschweiler (in the near of Aachen).
In this role you will be managing activities in the Quality Team that are needed to support China Drug Master File (DMF) submissions.
upmaintain Master Specifications for different product groups in China
Manage all relevant documents concerning the Master Specifications
Manage the inclusion of products in the specifications as compliant to the YBB requirements
Consult the relevant SAP Subject Matter Expert on test suite creationsimplementations
Review 3 batch test results/issue CoA for China DMF submission according to Section 5.0 for China DMFsubmission
Work with Order Fulfillment on specific item creations for China as well as on testing strategiesSite Quality Assurance (QA)
Coordinate Sampling Processes with the Laboratoriesthe Site QA to ensure that testingsreleases are completed on a timely basis. Support the setup of testingsreleases for new sites
Reviewescalate Quality System gaps in compliance to CFDA requirements
Review Stability Protocolssupport technical discussions on test specifications
Supportapprove Section 4.14.3 for China DMFsubmission
Provide historical analytical data to support capability studies for the compliance review to China requirements
Coordinate sample testings for the inclusionMaster Specifications
Support the business to reachkeep compliance with China regulatory requirements. Provide trainings to ensure an ongoing compliance to the China regulatory requirements
Analyze the content of relevant sections to the China DMF submissions including the review of raw data. Advise on changescoach the Site QA Managers
Support change control processes relating to the China DMF (raw materialfinish goods)related customer notifications
Apprenticeship as Laboratory Chemist (m/f/d)comparable; a Bachelor’s degree in Scienceanother technical field would be desirable (e. g. Chemistry)
Minimum 5 years of experience in a comparable role
Knowledge about rubber material would be a plus
Good technical understanding of manufacturing processes
Strong analytical skills
Very good communications skills
Excellent working knowledge of statistics
Strong project management skills
Basic knowledge of the Mandarin language will be an advantage, fluent English is a must
Readiness to travel
Internationality – As an American company, we live a global cooperation within international structures
Philanthropy – We value an appreciativefriendly work environment as well as flat hierarchies
Market-appropriate remuneration – We offer an attractive, market-oriented remuneration, including company social benefitspurchasing benefits
Social engagement – We support local aid organizations through various actions organized by our employees
Diversity – We at West value the wide range of our employees who make up our company
Safety – Occupational safety is our highest priority; we offer secure jobs in a sustainable industry
Development opportunities – Our employees benefitan extensive range of trainings as well asa constanttargeted employee development
Family-friendly culture – We attach great importance to reconciling private lifework; flexible working hours are a matter of course for us
Bitte geben Sie bei Ihrer Bewerbung die Referenznummer acjobs-st-27178 an.