April 2025

In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Your expected interactions are within your own team and direct supervisor.

This is a key hands-on, non-supervisory position. In this role, the Scientist initiates and executes stability studies for reference standards using appropriate compendial methods. Additionally, the incumbent will be responsible for performing analytical method development and validations for Impurity RS and maintaining safety and GLP environment in the lab.

Experience of formulation plant and knowledge of GLP & GDP. Should have knowledge of Microbiological testing, Environmental monitoring, Water system analysis, HVAC validation, QMS

Sterile, parenteral operations including aseptic processing, filling, sealing, filtration, production, QMS, batch manufacturing, autoclave, terminal sterilization, and packing. Production lines : Ophthalmic, Vial, PFS, LYO, Cartridges, and Bag. Machine exposure: Groninger, Optima, Dyno Truking, Bosch filling machines, Fedegari sterilizer, Steriline, Plumat, Pharmalab, and packing and labelling machines.

Must have excellent skills and knowledge of bioanalytical sample processing techniques. Very good understanding of current bioanalytical guidelines of various regulatory agencies such as USFDA, ANVISA, ICH etc.

Ensures that justified extension requests are made before the investigation deadline and that the investigations and CAPAs are closed within the required timeframe. Acts as a guardian of metrics by carrying out periodic follow-ups regarding investigations and CAPAs opened with internal and external partners. 

Operational Excellence - Build on technical expertise, expanding it in complementary directions. Use technical expertise and creativity to proactively identify potential problems and address them using appropriate resources in discussion with team leads.

Perform monitoring and site management work to ensure that sites are conducting the studyies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor, co-auditor for outsourced parties CROs, Service Providers, Vendors, Affiliates & Partners etc., associated with Sun Pharma