Description
Provide temporary Quality oversight for products manufactured at a CMO Site to ensure compliance with cGMP regulations and standards.Responsibilities include:
- Managing day to day quality operations for products at the CMO site
- Participating in weekly JMT meetings, as the PTQX representative
- Evaluating Deviations at the CMO which affect product
- Assessing Changes at the CMO that affect products.
- Leading Investigations for issues that occur at the CMO site
- Providing quality input on PQI, RCA, CAPAs etc
- Maintaining Quality initiatives at the CMO site
Skills:
- extensive sterile drug product and GMP experience, >10 years
- ability to influence and negotiate internally and with CMO
- experience with root cause and corrective action identification
- good verbal and written communication
- good presentation skills
- some travel may be required domestically, up to 25%
Education:
- BS in science
To find out more about Real please visit www.realstaffing.com