Development 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.

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Job Summary
We are looking for an individual for the Quality Assurance team to review and revise SOPs, oversee document control in product development, and conduct risk assessments. Responsibilities include reviewing specifications and STPs, ensuring data integrity, proposing QbD (Quality by Design) process changes, and participating in phase gate reviews.

Roles & Responsibilities
• You will be responsible for reviewing and revising SOPs (Standard Operating Procedures), obtaining supervisor approval for system-related revisions, and communicating SOP changes to all High-Performance Teams (HPTs). 
• Your role involves the preparation, review, approval, and control of documents generated during product development. 
• You will conduct, review, and approve risk assessments throughout the product development process. 
• You will review and approve specifications and Standard Testing Protocols (STPs) for various materials at different development stages, ensuring compliance with guidelines and SOPs during all stages of development and technology transfer.
• Your responsibilities include exercising control over data integrity, checking documentation and product development reports related to filings, and participating in proposing Quality by Design (QbD) process changes. 
• You will also conduct, review, and approve phase gates for drug products in coordination with development, and conduct self-inspections at the Integrated Product Development Organization (IPDO) according to the schedule. 
• You will be responsible for ensuring compliance in development laboratories, reviewing and approving facility/equipment qualifications at IPDO, and managing Quality notifications such as incidents and change controls through the Quality management system.

Qualifications

Educational qualification: A Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related field; advanced degree in Pharmaceutical Sciences or Regulatory Affairs is advantageous

Minimum work experience: 5-7 years of experience in the pharmaceutical industry, with a focus on product development and quality management

Skills & attributes:
Technical Skills
• Thorough understanding and practical application of regulatory requirements in pharmaceutical development.
• Proficient in implementing Quality by Design (QbD) principles in the product development process.
• Experience in reviewing, revising, and managing SOPs in alignment with industry standards.
• Expertise in conducting, reviewing, and approving risk assessments throughout the product development lifecycle.
• Strong focus on ensuring data integrity and compliance with documentation standards.
Behavioural skills
• Effective communication skills to relay SOP changes and ensure understanding across cross-functional teams.
• Meticulous attention to detail for reviewing specifications, STPs, and development reports to maintain data integrity.
• Ability to adapt to changes in the development process and propose improvements in the QbD 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...

" 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/#!/