Quality Assurance Associate (CAR-T)

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.

Job Description

We are currently seeking a highly motivated collaborative and experienced Quality Assurance (QA) personnel who can assist in establishing our CAR-T manufacturing GMP facility in Bangalore, India. The ideal candidate should have prior experience in field of biologics and cell therapy. This is a multi-disciplinary role and candidate will interface across multiple parts of the company.

Responsibilities

• To assist in ensuring the quality management system and all aspects of cGMP are effectively established, implemented and maintained in accordance with the regulatory and company standards.
• Provide QA oversight for all cGMP related activities (operations and QC)
• Review of quality system records such as change controls, deviations, complaints, investigations and customer complaints.
• Partners with other functions in for ensuring QMS elements are complying to regulatory and company standards.
• Works closely with other functions in a cooperative fashion and ensure project progression.
• To provide QA oversight to the commissioning and qualification activities on site.
• Develop, author, review and/or approve standard operating procedures, specifications, regulatory filing information and other controlled documents as required.
• May participate in internal/external audits and regulatory inspections.
• Perform or support any other tasks necessary to maintain the product quality and cGMP compliance.

Behavioral skills:

• Communication: Clearly communicate with team members, other departments, and management to ensure efficient workflow and collaboration.
• Critical Thinking: Evaluate data and information critically to make informed decisions and optimize quality/operations processes.
• Problem-Solving: Ability to analyze complex issues and develop effective solutions to ensure compliance with regulations.
• Teamwork: Collaborate with colleagues and cross-functional teams to achieve common objectives and improve processes.
• Time Management: Prioritize tasks, meet deadlines, and ensure timely completion of projects while maintaining quality standards.

Qualifications

• Bachelor’s degree or higher in Pharmacy or related life sciences field.
• 2 - 6 years of relevant experience in the biopharmaceutical or cell therapy industry.
• Experience with Cell and Gene therapy products preferred.
• Good knowledge of Good Manufacturing Practices.
• Familiarity and understanding of FDA, EU, and local industrial requirements.