Challenging position in a young and dynamic Biotech company with a direct report to the Global Head of QA.
Senior QA Professional Basel (m/f)
Our client is a biotechnology company located in the Basel area.
To act as Senior QA Professional and therefore as a QA representative and provide QA guidance to support the Supply Chain organization and R&D in order to ensure compliance with GMP/GDP as well as GLP/GCLP
To provide QA systems training to internal and cross-functional teams of research & development organization
To review and approve deviations, investigations, OOS and CAPAs change control of contracted manufacturing batches (Drug Substance, Drug Product)
To perform the GLP/GMP/GDP vendors' qualification, audits and ensure QA oversight on GLP/GMP/GDP activities
To perform and manage batches disposition
To manage complaints
To perform Annual Product Reviews
To facilitate the elaboration of CAPAs and ensure tracking and reporting
Direct report to the Global Head of QA
Bachelor`s degree in biological sciences, chemistry, pharmaceutical, or related field
More than 10 years active experience in Quality in a regulated pharmaceutical or biotechnological environment
Previous experience of having Responsible Person status according to Swiss law (SR 12.21) for releasing batches and Qualified Person according to Directive 2001/83/EC for Medicinal products for human use
Knowledge and practical experience of Biological DS/DP processes/manufacturing to hold the role of RP for release
Practical working knowledge of GMP/GDP/GLP/GCLP and all related EU & FDA regulatory requirements and ICH guidelines
Practical experience in conducting audits of GMP/GDP vendors for EU and FDA Regulatory Inspections
Ability to work effectively in a team and to work independently and in a multicultural environment
Fluency in German is required, good verbal and written communication in English
Excellent interpersonal skills
Practical knowledge in releasing products in Switzerland and EU
Ability to travel 20%, within EU and internationally
In case you are interested in joining a dynamic, fast-growing SME based in Basel and fulfilling the above mentioned requirements, we are looking forward to your application.