Specialist in hiring engineers, pharmacists and business managers for Life Science in Switzerland!
agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.
As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.
You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what's behind closed doors of the biggest projects of our client’s portfolio.
Responsibilities
* Maintainance and improvement of the quality system
* Preparation of batch releases including review of batch records
* Completion and approval of GMP documents
* Review and approval of biotechnology process validation documents (plans, protocols, reports)
* Management of changes (change control), anomalies, CAPA (Corrective Actions, Preventive Actions), OOS (Out of Specification), complaints
* Quality management of subcontractors (CMOs), monitoring of subcontractor qualification
* Creation and updating of procedures
* Creation of annual product quality reviews (APQR)
Your profile
* Industrial pharmacist, PharmD, engineering degree, master's degree in quality or in biotechnology
* Previous experience in the biotechnology industry
* Understanding of biotechnology production processes (USP, DSP, F&F)
* Willingness to work in an international environment
* Knowledge of cGMP regulatory requirements
* English and German spoken and written mandatory
Thank you for your interest in this opportunity, please note that only the selected candidates for a first exchange will be contacted.
Seniority level
Associate
Employment type
Full-time
Job function
Manufacturing and Quality Assurance
Location
Basel, Switzerland
Referrals increase your chances of interviewing at agap2 Switzerland by 2x
Get notified about new Quality Assurance Specialist jobs in Basel, Switzerland.
#J-18808-Ljbffr