Quality Assurance Specialist

Team Member - AQA

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

Job Summary
This role is for a Quality Assurance Specialist  – AQA reviewer - review of analytical data,  Analytical Compliance, responsible for ensuring end-to-end adherence to regulatory standards and SOPs in Quality Control (QC) laboratory operations, with a focus on analytical data integrity, and documentation oversight.

Roles & Responsibilities
• You will be responsible for reviewing all analytical data generated in the Quality Control laboratory—including electronic and raw data—ensuring accuracy and compliance with relevant SOPs.
• You will be responsible for reviewing instrument and equipment calibration records and audit trails to confirm reliability, data integrity, and GMP adherence.
• You will be responsible for preparing and reviewing documentation related to stability samples and ensuring that reference standards, impurity standards, working standards, and related records are maintained per applicable procedures.
• You will be responsible for performing and verifying SAP transactions related to laboratory workflows and data entries as outlined in SOPs, ensuring traceability and accuracy.

• You will be responsible for review of Audit trail for Quality control

• You will be responsible for reviewing and approving method validation and method transfer protocols and reports, as well as LIMS master data and control limit updates, ensuring analytical consistency across platforms.

Qualifications

Educational qualification: Graduation in Chemistry/Analytical Chemistry or Pharmacy is mandatory
Masters in Microbiology, Biochemistry,  Biotechnology, Chemistry/Analytical Chemistry or Pharmacy is preferred

Minimum work experience:
5+ years experience
Skills & attributes &Critical exposures
Functional Skills
• Regulatory Compliance
• Technical Documentation
• Change Control
• Laboratory Information
• Risk Management
• Chromatography
Resident Skills
• Product Quality (QA/QC)
• Current Good Manufacturing Practices (cGMPS)
• Good Laboratory Practice (GLP)
• Quality Management Systems (QMS)
Behavioural Skills
• Accuracy & Discipline – Upholds rigorous documentation and testing standards to ensure error-free, compliant results.
• Ownership – Proactively identifies risks, supports investigations, and maintains equipment readiness with accountability.
• Continuous Learning – Shares knowledge with new joiners, troubleshoots effectively, and contributes to laboratory excellence.
Critical exposures
• Experience in ensuring compliance with GMP, GLP, and global regulatory standards is desired.
• Exposure to executing analytical tests using techniques like HPLC, GC, FTIR, and UV-Vis, ensuring adherence to SOPs and regulatory requirements is preferred.
• Experience in maintaining accurate documentation and ensuring compliance with data integrity principles such as 21 CFR Part 11 and Annex 11, is desired.
• Experience in troubleshooting like Out-of-Specification (OOS) results and non-conformances, applying analytical methodologies to resolve deviations, is desired.

Experience Level

Mid Level