Job Description

Role Purpose

To lead In‑Process Quality Assurance activities for OSD formulation manufacturing, ensuring cGMP compliance, data integrity, inspection readiness, and Right‑First‑Time execution, in line with Quality Management System and global regulatory expectations.

Key Responsibilities

IPQA – Manufacturing & Packaging
Ensure real‑time QA oversight during dispensing, granulation, blending, compression, coating, ampoule and packing operations.
Review and ensure compliance of BMRs/BPRs, in‑process checks, and critical process parameters.
Manage line clearance, batch initiation, and batch closure activities.
Ensure adherence to ALCOA+ principles and data integrity requirements.
Support process validation, cleaning validation, and technology transfer batches.

Investigations & Quality Managment Systems
Lead and support deviations, OOS/OOT, incidents, and market complaints (if applicable).
Drive root cause analysis (RCA)



and ensure robust CAPA implementation and effectiveness checks.
Participate in change control, risk assessment, and continual improvement initiatives.

AQA – Analytical Quality Assurance
Review and approve analytical data related to raw materials, in‑process, finished products, stability, and cleaning samples.
Ensure compliance with analytical SOPs, test methods, specifications, and pharmacopeial requirements.
Review and support investigations related to OOS, OOT, atypical results, laboratory incidents, and method-related deviations.
Ensure data integrity compliance in QC laboratories, including audit trails, CDS, LIMS, and manual records.
Review method validation, method transfer, and analytical change control documents.
Participate in stability program review, trend analysis, and analytical risk assessments.

📌 Section Head Qa – Osd Baddi
🏢 Dr. Reddy's Laboratories
📍 Baddi