Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets.
Job Title – AR&D_Team Member _P2
Req Id – 26372
Location – India – Visakhapatnam
Purpose :Â To Support the team by executing Method Development & Validation strategies carry out specific experiments w.r.t. Product Development , analyse & share the reports as well as challenges with the team , take steps towards identifying new technologies to the department , Support in RA , DMF filling & participate in creating R&D knowledge flow within the function.
Job Description:
Key Responsibilities:
- Providing analytical support for CPP batches.
- Planning analysis to meet the delivery timelines in CPP AR&D.
- Performing & reviewing analytical data as per approved specification in line with the procedures with TI sheet/ATR/COA.
- Preparation of Instrument calibration schedule and ensure compliance to the schedule.
- Maintain optimal stock with respective to A&D lab requirements by indenting consumables, spares according to the lab consumption.
- Troubleshooting of analytical instrument with system engineers, following system breakdown & arranging rectification.
- Capable in Incident investigation procedures & Management of change procedures such as raising Change control, LIR & Incidents and ensuring on time closure of assigned CAPA’s.
- Providing scale up troubleshooting support through R&D lab.
- Preparation & regular review of SOP for CPP AR&D related activities and ensuring current practices are as per existing SOP.
- Evaluation of training needs, preparation of training calendar and training teams with respective to analysis, documentation, scientific reporting, Lab safety norms & Good Laboratory practices.
- Waste management to avoid accumulation of wastes generated in Lab.
- Maintaining good documentation practice, data integrity, housekeeping, safety & GLP norms in CPP AR&D.
- To aid the team with timely relevant data submission
- To reach understanding of the application of new technology.
- To ensure complete compliance & quality.
- Well aware of cGMP, cGLP and other regulatory guidelines such as ICH etc.
Operating Network:Â Product Development Teams, Plant DQA/QA/QC teams, Regulatory Teams, Manufacturing teams etc
Educational Qualification:  M Sc Chemistry / M Pharm
Experience Required:Â 3-4 years of experience in Quality Control/ Analytical Research & Development (API) in pharmaceutical industry
Key Personal Attributes:
- Â Self-starter, able to work independently with minimal supervison.
- Good Communication and writing skills.
- Process chemistry & Good analytical research.
- Learning aptitude to learn and understanding of analytical Techniques.