Description
Key Accountabilities/Core Job Responsibilities:- Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of drug substance (API) and drug products (DP)
- Independently reviews and approves executed manufacturing batch records, analytical data, and associated documentation, including any deviations and investigation reports related to material disposition.
- Coordinates, leads and conducts internal Quality Investigations as well as investigations at contract manufacturing organizations (CMOs).
- Performs person-in-plant (PIP) during manufacturing campaigns of API and DP at CMOs.
- Minimum BA/BS Degree in biological sciences, chemistry, or related field.
To find out more about Real Staffing please visit www.realstaffing.com