Sun Pharma

Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.

Responsible for executing technology transfer activities for solid oral dosage forms, including planning and performing Scale-up, Exhibit and Process Validation batches with optimal utilization of manpower, materials and equipment.

Sun Pharma is Indias No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries.

To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to take training before execution of allotted work & maintaining the training file.

Collaborating with the Product Development team to assess risk, stability, and capability using digital tools for product development. Identifying process automation opportunities in R&D and manufacturing sites and designing automation roadmaps to improve efficiency.

M.Pharm as Executive Pharmacokinetics. Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission. Sun Pharma

The incumbent will support the implementation of internal standards, provide study-level CDISC guidance, conduct quality reviews of deliverables from CRO partners, and ensure clinical data packages meet inspection-readiness criteria for global health authorities.

Responsible for the design, planning, operation and monitoring of the downstream group and this for development activities as well as for scale-up and GMP production 

B.Pharm / MSc; To perform the calibration of QC instruments as per calibration schedule. Overall upkeep of respective working bench as well as of the section as per GLP.