Quality Assurance Associate - Drug Product

Responsibilities:

• To Ensure shop floor compliance by involving in Line Clearance activities for Formulation, Filling, Optical Inspections and Packaging Activities.
• To monitor and ensure that all activities involved in Formulation, Filling, Optical Inspections and Packaging Activities are in compliance with GMP and Standard operating procedures.
• Review of Aseptic Media Fill Simulation Protocols and Reports. To Support for the Execution of Aseptic Media Fill Simulation activities.
• To Perform periodic verification of GMP records to ensure that data generated and documented at GMP floor are in compliance with ALCOA principle.
• Responsible for ensuring the drug product related Control Samples compliance.
• To ensure and comply the finished product time out of refrigeration and material management with in Production- Packing.
• Review and Approval of MFRs, BOMs, BPRs, SOPs (New, Revised & Executed Batch Records) and Validation protocols related to Formulation, Filling and Packaging Operations.
• Review of drug product MFR/BPR’s for commercial and developmental products manufactured in cGMP facility.
• Review of Change Controls, Incidents, CAPAs.
• To Perform investigation for deviations, and market complaints. To carryout/execute timely line clearance and carry out routine and non- routine spot check on shop floor.
• To Participate External and Internal Audits.
• Compilation of Annual product quality report (APQRs) for commercial drug products.
• Execution of Area, Process and Product change over line clearances for filling and packaging related activities.
• Sampling of Drug Product samples for LRA testing.
• To support for out of specification/out of limit (OOS/OOL) investigations related to product and environments.
• To Perform System / Process, audit trial for manufacturing equipment.
• To support, monitor Transport Validation activities.
• To verify temperature data of export shipments.

Educational Qualification - Bachelor's or Masters in Life Sciences

Minimum Work Experience- 8to 10 years of experience in a pharmaceutical company in Injectable products.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.

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