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Quality Assurance Associate
No salary listed
Senior
Master's, PharmD
Hyderabad, Telangana, India
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A master's degree in Life Science or a Master of Pharmacy degree.
- Six to eight years of industrial experience, including specific operational experience in Quality Assurance and Manufacturing for biosimilars.
- A solid understanding of quality systems and the ability to navigate organizational counter functions.
- In-depth knowledge of biopharmaceutical and pharmaceutical markets, including product knowledge, market trends, competitors, and customer needs.
- Understanding of global current Good Manufacturing Practice regulatory requirements, including U.S. Food and Drug Administration, European Union, and Indian regulatory requirements.
- Comprehensive knowledge of the organization's products, their characteristics, manufacturing processes, and quality requirements.
- Ability to understand and implement organizational policies and ensure compliance.
- Willingness and ability to work rotational shifts, including night shifts, weekends, and holidays, as operational requirements demand.
Responsibilities
- Verify compliance for activities in the respective counter function on a regular basis.
- Review real-time investigations and evaluate practices against defined standards to support smooth batch manufacturing and testing and ensure product quality and operational compliance.
- Oversee qualification, documentation, and traceability of Master and Working Cell Banks.
- Ensure compliance with Good Manufacturing Practice, EU Annex 1, and ICH guidelines for cell bank handling, storage, and distribution.
- Review and approve cell bank protocols, certificates of analysis, and characterization reports.
- Monitor environmental conditions and alarm systems for cell bank storage units, including liquid nitrogen tanks and freezers.
- Support audits and regulatory inspections by providing cell bank documentation and responses.
- Coordinate with manufacturing, quality control, and regulatory teams to ensure cell bank readiness for production.
- Manage deviations, Corrective and Preventive Actions, and change controls related to cell bank operations.
- Issue Working Cell Banks and Master Cell Banks as required and to manufacturing in accordance with approved guidelines, ensuring traceability and compliance.
- Review executed Drug Substance batch production records and associated documents for all products, and ensure timely deposition of reviewed documents to Document Control Quality Assurance.
- Review and approve Master Formula Records, batch production records, Bills of Materials, Standard Operating Procedures, Product Quality Reviews, action plans, and other relevant documents for existing and new products.
- Review and approve protocols and reports, including technology-transfer documents related to Drug Substance manufacturing processes.
- Initiate, review, and approve investigations, discrepancies, Corrective and Preventive Actions, Change Controls, and Quality Risk Management activities.
- Support internal and external audits, ensure timely closure of audit observations, and implement corrective actions.
- Monitor shop-floor activities for Good Manufacturing Practice compliance and conduct routine and non-routine spot checks.
- Provide line clearance for product changeovers and oversee critical activities according to Standard Operating Procedures across Drug Substance facilities.
- Create, revise, and review Standard Operating Procedures, forms, and other Drug Substance Quality Assurance documents as required.
- Periodically verify Good Manufacturing Practice records in alignment with ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
- Review and approve process and cleaning qualification and validation protocols and reports.
- Review system and process audit trails according to the defined schedule and perform audit-trail reviews for equipment.
About the company
Dr. Reddy's Laboratories focuses on affordable generic medicines and pharmaceutical ingredients. Its products include generic drugs and active pharmaceutical ingredients (APIs) produced in-house and distributed worldwide. The company grew from a Hyderabad-based startup in 1984, becoming the first Indian firm to export APIs to Europe in 1986 and to enter the U.S. market in the early 1990s, culminating in a 2001 NYSE listing that underscored its global standards. Today, the group operates in over 150 countries, supported by ongoing research and development to create new and improved medications. The core goal is to improve global health by providing high-quality, affordable healthcare solutions at scale.
Company Size
10,001+
Company Stage
IPO
Headquarters
Hyderabad, India
Founded
1984
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Simplify's Take
What believers are saying
- Obeda semaglutide launched in India on March 21, 2026 after the Novo cliff.
- Q1 FY27 revenue reached INR 8,071 crores on July 22, 2026, with 7.4% sequential growth.
- North America sales rebounded 19% sequentially, and net cash stayed INR 3,057 crores.
What critics are saying
- July 22, 2026 semaglutide batch provisions cut EBITDA and triggered investor investigations.
- North America revenue fell 41% year over year in Q1 FY27, exposing U.S. concentration.
- Any FDA finding at the semaglutide plant would freeze launches and crush margins for quarters.
What makes Dr. Reddy's Laboratories unique
- Dr. Reddy’s first-to-market Bosutinib launch on June 13, 2026 earned 180-day exclusivity.
- Canada approved generic semaglutide first, giving Dr. Reddy’s G7 mover advantage on April 28, 2026.
- Hyderabad-based MSN partnerships and global supply chains support complex injectables and oncology launches.
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Benefits
- Health Insurance
- Life Insurance
- Parental Leave
- Relocation Assistance
- Professional Development Budget
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