Responsible for end to end management of drug product visual inspection operations (Manual and Automated) as per SOPs, Batch Manufacturing Record, QMS item and cGMP norms. Responsible for total compliance of QMS elements.
- To coordinate team shift allocation according to the planned schedule and ensure timely approval of employee leave requests.
- To monitor, track and review QMS elements (Change controls, CAPA, incident management, SIR, market complaints etc.) and ensure the closure of the same on time.
- To review and compliance of Audit points.
- To plan optical inspection operations in compliance with delivery, quality and with safety.
- To involve in visual inspection projects activities (to prepare URS, involving in the FAT, SAT & equipment Qualification) for current and ongoing projects.
- To review and execute/ support the process validation protocols and its reports.
- To review the revised batch production records MFRs SOPs etc.
- To follow ensure clean room behaviors techniques team members.
- To identify reporting unsafe conditions acts.
- To coordinate packaging qualification activities and associated documentation in compliance with applicable procedures.
- Training staff member’s relevant cGMP aspect operations.
- To handle any other work assigned L+I Department charge.
B.Sc/B. Pharma/M.Sc/M.Pharma
About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.
Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/