The Pharmaceutical Manufacturing Investigations Specialist reports to the Manager of QA Investigations and is responsible for activities related to the investigations/deviations/CAPA process. Responsibilities include conducting the investigations, writing summary reports, suggesting and implementing appropriate corrective actions, and verifying effectiveness of CAPA. Additional responsibilities include administrative and compliance support to the Quality department within the Lupin Somerset facility. To be successful in this position a person must have a thorough understanding of the pharmaceutical manufacturing process including but not limited to Blending, Granulation, Encapsulation, and Compression. Above average writing and communication skills are imperative.
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 20 pounds occasionally. Generally work is performed in an office and or manufacturing environment.