Executive/Sr. Executive, PD (Formulation)

Activities related to new product development (Pre-formulation, Feasibility study, Lab batch, Stability batch preparation).

Record the development activity according to lab trial for formulation development initiative.

Process Technology Transfer (Feasibility study, assuring the resource availability) and Commercialization.

Process validation activities (Preparation of Protocol, execution and report generation)

Packaging validation activities (Preparation of Protocol, execution and report generation)

Stability management of pharmaceutical products under development phase (Preparation of stability protocol, loading sample in the chamber, withdrawing in a timely fashion and generation of report after the completion of stability study.)

Stability chamber management (Routine maintenance/calibration, performance check etc.)

Batch documents (manufacturing and packaging) preparation and review.

Preparation of sample for the Drug Testing Laboratory (DTL) (Sample preparation, documents related to DTL submission)

Preparation of documents (e.g. Recipe, Annexure) to testing and regulatory authority.

Prepare packaging material specification for Packaging Material Specification (PMS) approval.

Ensure the trouble-shooting activity of the products to solve any product problem by maintaining compliance with quality.

Raise Document initiating form Change Control Report (CCR), Change Document Report (CDR), Handling of Deviation and perform risk assessment as per requirement