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.

Educational Qualification

- B.Pharm / M.Pharm / M.Sc (Chemistry or relevant discipline)

Experience

- 15 years of experience in QA - OSD formulation manufacturing
- Minimum 2-3 years in a senior executive / team leadership role
- Exposure to AQA, OOT and OOS Investigation

📌 Section Head QA – OSD (Baddi)
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📍 Baddi