Roles and Responsibilities:
- To have knowledge of Product Development, pre-formulation studies, laboratory scale/ pilot batches, identification of CPPs and CQAs, and evaluation of the in-process, finished product, and stability samples.
- To be well versed with technology transfer activity from R&D to site and site to site, manufacturing process, process validation, and statistical tools used for the data evaluation.
- Have hands-on experience in manufacturing operation of OSD, SSD formulation, and equipment.
- Handling of QMS documents like. Incident / Deviation investigation, change control, etc.
- Have knowledge of electronic data management of manufacturing systems.
- Review of QMS documents such as OOS, OOT, Incidents Deviation, CAPA, and product market complaints,
- Performing basic statistical evaluation of data.
- Performing root cause analysis of an occurred OOS, deviation / a typical event, or Failure investigation using investigation tools viz. Fishbone diagram, 5 WHY Analysis, IS IS NOT Analysis, Peeling the Onion, Process Mapping / Flow Charts, Interviews, and Brain Storming.
- Reviewing the adequacy of CAPAs with respect to the root cause investigations. To verify if the CAPA EC is well defined.
- Responding to internal as well as external audit observations with respect to investigation-related observations.
- Knowledge of relevant Guidelines, and USFDA inspection exposure.
Desired Candidate Profile
- Excellent Investigation writing skills, excellent communication (written & oral) and documentation skills, well versed with Regulatory intelligence in Pharma Industry.
- Knowledge on relevant Guidelines
Manufacturing Operation (OSD and SSD), Product Development, Technology Transfer, Process Validation, Cleaning Validation, and Investigations
Candidates with excellent written documentation skills and actively performing investigations will be preferred. Specialized training in Investigations will be an advantage.