Roles and Responsibilities:
- To have good knowledge in Quality Control instrumental techniques & various chromatographic software.
- To be well versed with method validations, pharmacopeia requirements, chromatographic practices, etc.
- Have hands-on experience in handling / testing various dosage forms & handling sophisticated instruments.
- Handling of QMS documents like OOS, OOT, Incident / Deviation investigation, Lab event, etc.
- Knowledge of relevant Guidelines, and USFDA inspection exposure.
- Have knowledge of electronic data management of Laboratory 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.
- To be able to identify and notify atypical product trends while reviewing of investigations.
Desired Candidate Profile
- Excellent Investigation writing skills, excellent communication (written & oral) and documentation skills, well versed with Regulatory intelligence in Pharma Industry
- Knowledge of relevant Guidelines
- QC lab operations and well versed with various techniques, well versed with Analytical method development, Technology Transfer,
- Chromatographic Integrations and Investigations
Candidates with excellent written documentation skills and actively performing investigations will be preferred. Specialized training in Investigations will be an advantage.