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Quality Assurance Manager (m / f / d)
Datalynx AGBasel, CHVor 30+ Tagen
StellenbeschreibungScientific education (Master degree) in analytical chemistry / biochemistry / life science Multi-year, industrial work experience of 7 years minimum in the analytical-pharmaceutical environment preferably experience in QA Strong problem-solving skills to meet business objectives Excellent interpersonal skills and teamwork spirit Ability to collaborate in a dynamic, cross-functional matrix environment Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.) Solid background in data integrity and computerized systems risk assessment and project support Experience as an auditor is an asset Fluency in English and wiliness to learn German is required Flexible work models such as part-time and remote work Minimum 28.5 vacation days
Together with Primetrack AG and Datalynx AG, Skillcloud AG is part of the Datalynx Group. Skillcloud AG serves as the point of contact for personnel matters as well as for the search and selection of executives and specialists.
Tasks & Responsibilities
- Review and approval of SOP’s, protocols, reports, Certificate of Analysis and other quality documents
- Support quality investigation of deviations and Out of Specification (OOS)
- Maintenance, recording and processing of corrective and preventive measures (CAPA)
- Performing internal audits
- Organization and management of customer audits, and inspections
- Apply and interpret audit and compliance requirements
- Act as QA point of contact for customers
- Support for GMP training
General Information
Start date : ASAP
Duration : Permanent position
Workload : %
Work location : Basel
Must Haves
Benefits