Dr. Reddy’s Laboratories Hiring Quality Assurance Associate – QMS – Biologics in Hyderabad

Dr. Reddy’s Laboratories Ltd. is hiring a Quality Assurance Associate – QMS – Biologics (full-time) for its Global Biosimilars / Biologics quality organisation. Candidates need a B.Pharm. or Post-Graduation (Life Sciences) and 4 years of industrial experience.

Job Details

Company: Dr. Reddy’s Laboratories Ltd.

Job Title: Quality Assurance Associate – QMS – Biologics

Location: Hyderabad

Job Type: Full-time

Job Family: Quality (Quality Assurance sub-family)

Department: Global Biosimilars / Biologics quality organisation

Job Description

The role sits in the Quality family (Quality Assurance sub-family) and focuses on QMS adherence, analytical data review, CMO batch records, method transfer/validation documentation, stability documentation, and shop-floor QC compliance support.

Job Summary: Verify compliance for activities in the respective counter function regularly. Review real-time investigations, support smooth batch manufacturing and testing activities, and evaluate practices against defined standards so product quality and operational compliance stay aligned with the regulatory framework and global standards.

Key Responsibilities

  • Involve in analytical data review and approval.
  • Review of batch analytical records for batches manufactured at CMO.
  • Review and approvals of analytical method transfer, validation protocols and reports.
  • Preparation, review and approvals of study protocols and reports.
  • Review and approvals of stability protocols, reports and related documentation from product stability studies.
  • Preparation, review and approvals of procedural documents such as SOPs / STPs / Specifications and ROAs pertaining to Quality Control in accordance with current QA requirements.
  • Analyst qualification review and authorization; instrument calibration review and authorization.
  • Assuring compliance on the QC floor through lab rounds; participate in QC Analytics LDM and update quality slides.
  • Support audit-related activities as required; QC instrument audit-trail support.
  • Check adherence to QMS elements such as change control, incident management and CAPA on the shop floor.
  • Support the supervisor in investigations related to complaints, batch failures, OOS/OOT results and incidents by collating data and conducting interviews.
  • Coordinate with cross-functional teams to drive investigations, root-cause analysis, CAPA documentation, implementation verification and effectiveness monitoring.
  • Support internal and external audits (information, documents, clarifications) and track closure of audit action items with user departments.

Eligibility Criteria

  • Educational qualification: B.Pharm. or Post-Graduation (Life Sciences).
  • Minimum work experience: 4 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering & Development.

Required Skills

Technical skills:

  • Solid understanding of Quality Systems.
  • Familiarity with global cGMP (FDA, EU, Indian regulators).
  • Product and process knowledge in biopharma/pharma.
  • Ability to implement organisational policies and ensure compliance.

Behavioural skills:

  • Continuous learning
  • Communication and influencing
  • Analytical/logical thinking
  • Self-motivation
  • Teamwork and adaptability

Additional Information

Benefits: Learning programmes, medical coverage, life coverage, joining/relocation support and family support as per company norms.

About Dr. Reddy’s

Dr. Reddy’s is a leading multinational pharmaceutical company with R&D centres, manufacturing facilities or commercial presence across many countries. The Biologics business operates in Global Biosimilars with a portfolio spanning key therapeutic areas, end-to-end product development (clone development, upstream/downstream, bioanalytical development, formulation), clinical/regulatory execution for biosimilar programmes, and commercial-scale manufacturing across technology platforms.

CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE

Apply through the official Dr. Reddy’s SmartRecruiters listing linked above.