Quality Assurance Associate

Job summary
We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves quality oversight of DS manufacturing facilities reviewing real-time investigations ensuring smooth batch manufacturing and evaluating practices against defined standards to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

Roles & Responsibilities

1. Review of executed drug substance BPRs and related documents for all products and deposition to DCQA.
2. Review and approval of MFRs BPRs BOMs SOPs PQRs action plans and other documents for existing and upcoming products.
3. Review and approval of various protocols and reports including tech-transfer reports related to the DS manufacturing process.
4. Initiation approvals and review of investigations discrepancies CAPAs Change controls QRMs.
5. Audit support and audit observation closure for internal and external audits.
6. Review of shop floor activities and ensure GMP compliance.
7. Provide line clearance for product change over whenever required in any DS facility and any other critical activity when required as per SOP.
8. Creation/ Revision/ Review of new SOPs forms and any documents related to DS-QA upon requirement.
9. To perform periodic verification of GMP records in compliance with ALCOA principle.
10. Review and approval of Qualification/Validation documents.
11. To carry out routine and non-routines spot checks on shop floor.
12. To review system and process audit trail as per the schedule.
13. To perform Audit Trails for the equipments
14. Issuance of WCB and MCB

Qualifications :

Educational qualification: (Life Science)  /M Pharm 

Minimum work experience: 10-12  years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars)

Skills & attributes:

Technical Skills
A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.
In-depth knowledge and comprehension of the Bio Pharma and Pharma markets including product knowledge market trends competitors and customer needs.
Understanding and familiarity with global cGMP (Current GMP) regulatory requirements including those set by FDA (U.S. Food and Drug Administration) EU (European Union) and Indian regulatory authorities.
Awareness of broader market dynamics industry trends and factors influencing the pharmaceutical market.
Comprehensive knowledge of the specific products associated with the pharmaceutical organization including their characteristics manufacturing processes and quality requirements.
Ability to understand and implement organizational policies and ensuring compliance.

Behavioural skills
Demonstrates a commitment to continuous learning.
Strong communicating and influencing skills.
Displays analytical and logical thinking abilities.
Is self-motivated and takes initiative.
Adaptability to the work environment along with being a team player.
Ability to go beyond boundaries showcasing a proactive and innovative approach.

Ability to work in shifts 

Additional Information :

About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-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 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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

Remote Work :

No

Employment Type :

Full-time