Quality Assurance Assistant (f/m/d) in Full Time 

About

PreviPharma Consulting GmbH is an internationally active research company in the field of plasma
protein based therapeutic development. Together with our partners from the plasma fractionation
industry such as plasma fractionators, plasma donation centers and technology suppliers, our
continuously growing team develops new medical and technological solutions from plasma donation to
address unmet medical need.
We are expanding our team at the CUBEX41, the innovative center for medical technologies in
Mannheim.

Area of responsibility

• Write and verify SOP’s and other policies. 
• Control of documents; maintenance of records and other elements of the QMS including AdobeSign. 
• Ensure that trending and review of CAPAs, KPIs and document review tracking is carried out. 
• Coordinate equipment maintenance by external contractors and monitor outsourced analysis based on company needs. 
• Participate in weekly QA meetings and assist QA Manager with product reviews and recalls, CAPA’s, Change Controls, Complaints, Out of Specifications and other documentation such as SOP’s and forms. 

Experience and Qualifications

• Completed vocational training as BTA/MTA/CTA/PTA/Lab assistant (f/m/d) with +4 years of working experience or B.Sc. in Biology or Life Science; 
• Experience of working in a highly regulated (e.g. GMP) environment and using a QMS. 
• Experience in QA would be beneficial, but is not essential as full training will be provided.
• Strong written and verbal communication abilities (English and German). 
• Proficiency in developing and reviewing documentation and SOP’s. 
• Previous experience in quality assurance, preferably in the pharmaceutical industry. 
• Structured, organized and autonomous working 
• Distinct capacity for teamwork, reliability, high engagement and strong communication skills 

We offer

• Permanent employment with challenging and responsible tasks and a high potential of development
• Systematic and practical training by a cooperative, motivated team, in a forward-thinking branch