About the Company
Sun pharma is an Indian manufacturing pharmaceutical company with more than 40 manufacturing sites and more than 100 countries serving markets with more than 30000 employees and 2000 marketed products.
The company established in 1983 with 2-person marketing team and in 1994 launched and IPO. In 1991 it established an process development R & D center primarily. Now it has more than 2000 scientists.
The products include anti retrovirals, OTC drugs, API (Active pharmaceutical substances) urology, nephrology and so on.
About the Job
Locations of job: Tandalja R&D
Candidate hire is responsible for analysing different samples of various markets that are being developed by CRD scientist and PDR scientist
required to have knowledge on high performance liquid chromatography ultraviolet spectroscopy dissolution
Need to have strong skills on empower ultraviolet software
Adequate knowledge on chromatography spectrophotometry
Manager-1 R&D
Location: Same as above
Roles :
able to finalise packaging configuration for exhibit batches of generic products as per requirement
required to prepare FMEA, And coordinate with NPI and planning team for launch of NDA and ANDA
Able to support the regulated team on ANDA and NDA filing for regulatory market
Need to support plan for validation and troubleshooting activities as well as participate in FAT machines
Required to prepare the packing documentation like justification reports pack style as per regulatory requirements
need to prepare and revise packing material specifications or ATP
Able to coordinate with cross functional team like regulatory affairs plant ppic marketing and PMO for completion of task
preparation of MPC and new vendor development for packing material
For Quality Assurance:
Location of the Job: Panoli
Roles :
Able to handle change control activities like initiation review approval of change control monitor and recommended action in track wise system
required to initiate and close planned deviation track follow up for the closure and effectiveness of impact assessment monitor of refunded action in track wise system
able to handle CAPA activities and track for review and approval
able to handle product quality complaint activities like initiation of product quality complaint and risk assessment prepare and close investigations track and monitor open quality product complaints and annual trend of product quality complaint
initiation and preparation review approval of investigations open investigation tracking trend of unplanned deviation
Need to prepare and review annual products quality review continuous process verification and 21st CFR activities
Handling of data compilation and submission for preparation of quarterly metrics reports
able to handle other activities instructed by manager from time to time