Team Members – Investigation (QC) | Glenmark Pharma | Mumbai

Job Description

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

Functional – 

• Excellent Investigation writing skills, excellent communication (written & oral) and documentation skills, well versed with Regulatory intelligence in Pharma Industry
• Knowledge of relevant Guidelines

Technical –

• 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.