Quality Assurance Associate Engineering

1. Responsible for qualification/re-qualification of facilities equipment analytical instruments & utilities used in manufacturing facility and related activities.
2. To coordinate manage proper functioning of Quality Assurance with continue support and co-operation with stakeholders inline with cGMP norms implementation with regulatory and statutory compliance.
3. Part of QA validation team to support all aspects of Qualification and Validation Program including qualification & requalification of equipment utility system and GMP facility.
4. Ensure implementation of standards for cGMP Quality and Safety in the GMP engineering operations of Biologics facility.
5. Ensuring adherence of requirement of VMPs Protocols SOPs and other functional/operational procedures.
6. Coordinate review evaluate & approve protocols/reports of equipment utilities system and GMP facility.
7. Ensuring all the equipment systems instruments utilities facilities used in GMP areas are qualified and released for regular GMP as per the effective qualification procedures.
8. Creating workflow aids aligned to on facility and equipment qualification procedures and educating stakeholders on qualification aspects.
9. Shop floor visit and GEMBA walk for all existing facility green field and brown field under execution projects and stand-alone equipment qualifications and ensure compliance.
10. Vendor site audits for outsourced validation studies like calibrations and qualification/re-qualification audits for suppliers.
11. To highlight quality related problems in time seek their resolution and providing QA expertise for assessing impacts on incidents/deviations and support investigations & troubleshooting CAPA Change requests addendum amendments report related to engineering processes.
12. Review evaluation Verification closure of the change controls incidents investigations CAPA and provide the QA comments and oversee the implementation respectively (as applicable).
13. Review approval for validation engineering related GMP documentation including but not limited to; Site Master File (SMF) Validation Master Plan (VMP) Validation Plans Standard Operating Procedures (SOPs) Work instructions Protocol/Report Summary reports and ensure consistency and compliance to regulatory requirements.
14. Provide support as needed in the regulatory audits/inspections.
15. Participate in risk assessment and evaluation process and review evaluate approve the risk assessment reports.
16. Compilation of daily weekly and monthly reports and their submission to the quality management review meeting (QRM) and identify the area of improvements.
17. Ensure systems comply with regulatory requirements such as FDA 21 CFR Part 11 EU Annex 11 and other relevant regulations.
18. Identify assess and mitigate ENG. & IT-related risks to ensure compliance and business continuity
19. Ensure implementation of Standards for GxP cGMP Quality Systems at Biologics Operations.

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  Work :

No

Employment Type :

Full-time