Quality Assurance Manager
Where
- Indianapolis, IN
What you'll be doing
- Ensuring compliance of the product stability program with international regulatory guidelines. Administration of all product stability programs. Generation and analysis of trend data using relevant statistical packages and escalation of trends to management. To present and distribute data and information generated by the product stability programs. Supervision of the annual product reviews for licensed products in accordance with EU and US legal requirements. Generation of detailed written reports and presentation of laboratory data. Generation of regulatory submission data to support changes to expiry dates for biologics. Perform routine duties as required in quality control laboratories in order to ensure the timely generation of accurate data and information. Ensure all activities follow standard operating procedures and protocols are performed in compliance with GxP. Maintain and develop up to date knowledge on stability regulatory expectations.
What your background should be
- Experience in a pharmaceutical company. Strong knowledge of regulator requirements.
Required Schooling / Training
- Bachelor degree in science
Who is the client company
- The company is a staffing agency that matches qualified candidates with top companies worldwide.
- If you are interested in this position, send your resume to apply@kochdavis.com
