Quality Assurance Associate - Engineering

Quality Assurance Associate - Engineering

Company Description

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

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Job Description

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 VMP’s, Protocol’s, SOP’s 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 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/#!/ 

Experience Level

Mid Level