Quality Assurance Associate

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.

Job summary
We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing  IT infrastructure compliance and System life cycle Management of Equipment's/Instruments/facilities/Utilities , ensuring CSV life cycle management as per 21 CFR part 11 and GAMP5  standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

Roles & Responsibilities

• Ability to review and approve validation deliverables and applicable procedures.
• Ability to perform Project coordination, integration with CFT and Development team in delivering the objectives with compliance.
• Provide Support for Development of Quality or IT policies and procedures in line with regulatory requirements related to IT Applications
• You will be responsible for issuance, availability, and adherence of approved procedures to the manufacturing team.
• Providing oversight for validation, engineering related GMP documentation including, but not limited to validation plans, SOPs, work instructions, protocols, summary reports and ensure consistency and compliance to regulatory requirements.
• Ensuring adherence of requirement of SOPs and other procedures.
• Manage proper functioning of Quality Assurance with continue support and co-operation with stakeholders in line with cGMP norms implementation with regulatory and statutory compliance.
• Ensuring GMP compliance at Engineering functions of QA Biologics for Drug Substance (DS), Drug Product (DP), Equipment, Utility, System and GMP facility.
• Part of QA validation team to support all aspects of Qualification and Validation Program, including qualification & requalification of equipment, utility, system and GMP facility.
• Ensuring Commissioning Qualification, Modification/expansion, Requalification and revamping of equipment/utility/area and facility.
• Ensure implementation of standards for cGMP, Quality and Safety in the GMP engineering operations of Biologics facility.
• Coordinate, review, evaluate & approve protocols/reports of equipment, utilities, system and GMP facility.
• Responsible to overlook on engineering services provided by OEM/Third parties.
• Oversight on engineering (facility/utility) related issues inside GMP areas.
• To highlight quality related problems in time, seek their resolution and providing QA expertise for assessing impacts on incidents and support investigations & troubleshooting, CAPA, Change requests, addendum, amendments report related to engineering processes.
• Review, evaluation, approval of the change controls, incidents, investigations, CAPA and provide the QA comments and oversee the implementation respectively (as applicable).
• Providing oversight, 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.
• Providing guidance to stakeholders/functions on qualification/validation matters and to ensuring effective systems are maintained and improved as a part of continuous improvement plan.   
• Provide support as needed in the regulatory audits/inspections.
• Participate in risk assessment and evaluation process and review, evaluate, approve the risk assessment reports.
•  You will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor.
• You will coordinate with cross-functional teams to facilitate and drive the investigation process, conduct a thorough root cause analysis, document CAPA, verify implementation within the agreed timeline, and monitor its effectiveness over time.
• You will be responsible for supporting or assigning personnel to assist in internal and external audit activities, following the instructions of superiors, providing necessary information, documents, and clarifications to supervisors during actual audits, and maintaining appropriate records.
• You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed.
• Ability to review and approval of GXP and Non GXP tickets.
• Ability to review and Approval of IT infrastructure compliance.
• Ability to review and approval of Backup and restoration procedures and disaster management.
• Ability to review and approve the GXP Assessment as per the GAMP 5 category.
• Ability to review and approval of Quality risk Assessment accordingly allocation of mitigation plan and ensured compliance
• Ability to review and approval of the Configuration specification, URS, Design Document (Software & Hardware ), IQ and OQ test script as per the validation plan.
• Ability to perform Audit trial verification for Software, Equipment and Instruments
• Familiar with 21 CFR Part 11, EUGMP Annexure 11 and other equivalent regulations
• Computer System Validation: Review & approval of documentation related to IT systems during qualification/validation & lifecycle management.

Educational qualification: AB. Pharm, BE/BTech. or Post-Graduation (Life Sciences/Engineering).

Minimum work experience: 8 - 12  years of industrial experience with specific operational experience in Quality Assurance, Commissioning Qualification, Validation, Engineering & ITQA.

Skills & attributes:

Technical Skills
• A solid understanding of Quality Assurance, Commissioning Qualification, Validation, Engineering & ITQA and Quality Systems and the ability to comprehend and navigate counter functions within the organization.
• 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.

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/#!/