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 Summary

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

" Roles & Responsibilities

• Responsible for ensuring cGMP compliance at Engineering & IT functions of QA Biologics for Drug Substance (DS), Drug Product (DP), Equipment, Utility, System & GMP facility.
• Part of QA validation team to support all aspects of qualification and validation program, including qualification and requalification of all manufacturing equipment’s, utilities (Black utilities & Clean utilities) and GMP facilities.
• Ensure implementation of standards for cGMP, quality systems and safety in the GMP Engineering operations of Biologics facility.
• Ensuring adherence of requirement of SOPs and other functional/Operational procedures for GxP system compliance such as Backup, Restorations, Audit trail review, Date and Time Synchronization, Periodic review of Computerized Systems, Privileges Verification .
• Overview and participation in IT/CSV related activities where QA expertise is sought
• Providing oversight on qualification validation for computerized system including review and approval of related document.
• Oversight on engineering (facility/utility) related issues inside GMP areas though walk downs.
• Review, evaluation of change controls, Deviations, Deviation Investigations, CAPA, provide the QA comments, and oversee the implementation related to computerized systems.
• Providing oversight, review, approval for validation, engineering related GMP documentation including, but not limited to; Risk assessment, GxP assessment, validation plans, SOPs, work instructions, protocols, summary reports, system qualification related document to ensure consistency and compliance to regulatory requirements.
• Review and approve computer system related validation/qualification documents.
• Review & Approval of documentation related to IT systems during qualification & lifecycle management.
• Provide support as needed in the regulatory audits/ inspections.
• Review and verify the System & Process Audit Trails for Engineering & IT GxP Systems.
• GxP and Non GXP ticket verification and closure.
• Review & Approvals of Training Need Identification (TNI) of Engineering & IT functions.
• 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.
• Ensure implementation of Standards for GxP, cGMP, Quality Systems at Biologics Operations.
• Provide oversights for qualification and validation for engineering systems, including review and approval of related document.
• Oversight on engineering (facility/Utility) related activities inside GMP areas.
• Auditing vendors and services provider’s/ partners operation if required.
• Any specific job assigned by  Head QA based on experience and competency.

Educational Qualification

A B. Pharm, Engineering, IT or Post-Graduation (Life Sciences)

Minimum Work Experience

6-10 years of industrial experience with specific operational experience in CSV, IT, Manufacturing, Quality Assurance,  Engineering, Commissioning Qualification, Validation.

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.

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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...

" Benefits Offered

At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards...

" 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...

For more details, please visit our career website at https://careers.drreddys.com/#!/

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