Quality Assurance Associate Drug Product
- Dr. Reddy’s Laboratories Hiring Quality Assurance Associate – Drug Product in Hyderabad
- Company Overview
- Job Role & Responsibilities
- GMP Compliance & Shop Floor QA
- Batch Records & Documentation Review
- Investigations & Quality Events
- Aseptic Operations & Validation Support
- Audits & Continuous Improvement
- Eligibility / Qualifications
- Educational Qualifications
- Experience Requirements
- Behavioral & Technical Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Summary Table
Dr. Reddy’s Laboratories Hiring Quality Assurance Associate – Drug Product in Hyderabad
Dr. Reddy’s Laboratories Limited is hiring for the position of Quality Assurance Associate – Drug Product at its Hyderabad, Telangana facility. This full-time, on-site opportunity is within the Biologics / Injectable Drug Product Quality Assurance function. The opening is designed for experienced professionals with 3 to 8 years of experience in injectable pharmaceutical manufacturing environments. This role supports GMP compliance, batch release activities, audits, and aseptic operations within a global biosimilars business. The position is based in Hyderabad, Telangana, one of India’s leading pharmaceutical and biologics manufacturing hubs.
This opportunity is ideal for quality assurance professionals seeking long-term careers in sterile manufacturing, injectable quality systems, and global regulated pharmaceutical operations.
Company Overview
Dr. Reddy’s Laboratories Limited is a leading multinational pharmaceutical company with a strong presence across research, development, manufacturing, and commercialization of generic medicines, biosimilars, and innovative pharmaceutical products. Founded in 1984, the company has grown into a global organization with operations across 66 countries and a workforce of over 24,000 professionals.
Dr. Reddy’s operates with a clear purpose of accelerating access to affordable and innovative medicines while maintaining uncompromising standards of quality, compliance, and corporate governance. The company’s focus on deep science, patient safety, sustainability, and ethical practices has positioned it as a trusted name in global healthcare.
The Biologics division at Dr. Reddy’s is a fast-growing vertical with a robust biosimilars portfolio spanning multiple therapeutic areas. With fully integrated development, manufacturing, clinical, and regulatory capabilities, the organization continues to expand its global footprint while delivering high-quality injectable and biologic medicines to patients worldwide.
Job Role & Responsibilities
The Quality Assurance Associate – Drug Product is responsible for ensuring cGMP compliance across injectable manufacturing, filling, inspection, and packaging operations. The role involves shop floor QA oversight, documentation review, deviation handling, and audit participation within a regulated sterile manufacturing environment.
GMP Compliance & Shop Floor QA
- Perform periodic verification of GMP records to ensure data integrity and adherence to ALCOA principles
- Ensure shop floor compliance through active participation in line clearance activities for formulation, filling, optical inspection, and packaging operations
- Execute area, process, and product changeover line clearances during filling and packaging activities across shifts
- Perform routine and non-routine spot checks on the shop floor to ensure compliance with cGMP requirements
Batch Records & Documentation Review
- Review and approve executed batch records related to filling and packaging operations
- Review and approve SOPs, BPRs, MFRs, BOMs, and validation-related documents
- Review and approve change controls, incidents, deviations, and CAPA documentation
- Review drug product MFRs and BPRs for both commercial and developmental products manufactured in cGMP facilities
Investigations & Quality Events
- Perform investigations related to deviations, market complaints, and non-conformances
- Support out-of-specification and out-of-limit investigations related to products and manufacturing environments
- Ensure timely documentation, root cause analysis, and closure of quality events
Aseptic Operations & Validation Support
- Support aseptic area qualification and airflow visualization studies
- Execute and review media fill (aseptic simulation) protocols as per annual planning schedules
- Review and approve media fill protocols and final reports
Audits & Continuous Improvement
- Participate in internal audits, external audits, and regulatory inspections
- Support preparation and compilation of Annual Product Quality Reports for commercial drug products
- Provide quality support for new product launches, especially related to drug product packaging
This role requires a strong understanding of sterile manufacturing processes, quality systems, and regulatory expectations in injectable and biologics environments.
Eligibility / Qualifications
This position is suitable for experienced QA professionals with hands-on exposure to injectable pharmaceutical manufacturing.
Educational Qualifications
Eligible educational backgrounds include:
B.Sc Life Sciences, M.Sc Life Sciences, B.Pharm, M.Pharm, B.Sc Biotechnology, M.Sc Biotechnology, B.Sc Microbiology, M.Sc Microbiology
Experience Requirements
- 3 to 8 years of experience in Quality Assurance within a pharmaceutical manufacturing company
- Mandatory experience in injectable or sterile drug product manufacturing
- Exposure to filling, inspection, packaging, and aseptic operations is required
Behavioral & Technical Skills
- Strong communication and interpersonal skills
- Analytical mindset with effective problem-solving abilities
- Ability to collaborate with cross-functional teams
- High level of documentation discipline and compliance orientation
Location & Salary
Job Location: Hyderabad, Telangana, India
This is a full-time, on-site role based at Dr. Reddy’s injectable and biologics manufacturing facility in Hyderabad. Salary and compensation will be offered as per industry standards and will be commensurate with the candidate’s experience, educational background, and internal compensation structure. The role offers exposure to global biologics operations, structured career growth, and long-term professional stability.
Application Process
Interested and eligible candidates must apply through Dr. Reddy’s official career platform or LinkedIn job portal using the link below:
Apply Online:
https://www.linkedin.com/jobs/view/4370963517/
Candidates are encouraged to apply at the earliest, as the position is actively hiring.
Frequently Asked Questions (FAQs)
Who can apply for the Quality Assurance Associate – Drug Product role?
Candidates with 3–8 years of injectable QA experience and a life sciences or pharmacy background are eligible.
Is this role related to biologics and injectables?
Yes. The position supports injectable drug products within the Biologics business.
Does the role involve aseptic operations?
Yes. The role includes media fills, aseptic area qualification, and airflow visualization support.
Is this a permanent position?
Yes. This is a full-time permanent role at Dr. Reddy’s Laboratories.
Does this role involve audit participation?
Yes. The associate will participate in both internal and external audits.
Summary Table
| Company | Dr. Reddy’s Laboratories Limited |
|---|---|
| Vacancies | Quality Assurance Associate – Drug Product |
| Required Education | B.Sc Life Sciences, M.Sc Life Sciences, B.Pharm, M.Pharm, Biotechnology, Microbiology |
| Experience | 3 to 8 Years |
To apply for this job please visit www.linkedin.com.
