Role & Responsibilities:

- Ensure that all pharmaceutical products developed within the R&D; department meet the highest quality standards and regulatory expectations.
- Prepare and review regulatory dossier documents for submission to DCGI, ROW, and export market authorities.
- Verify that all documentation complies with applicable regulatory guidelines and quality requirements.
- Implement and maintain quality assurance systems and procedures related to dosage form development and preparation.
- Ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory standards.
- Collect, organize, and review documentation from F&D;, ADL, and other related departments for regulatory and quality purposes.
- Prepare and review SOPs, Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Process Validation (PV) Protocols/Reports,



and Stability Protocols for accuracy and compliance.
- Manage and maintain all quality documentation, including SOPs, batch records, and test reports.
- Compile and review Product Development Reports (PDRs) to capture detailed formulation and development data.
- Ensure all laboratory and production equipment are calibrated as per the defined schedule, and calibration records are properly maintained.

Preferred Candidate Profile:

- Must have experience in Oral Solid Dosage (OSD) formulations.
- Robust understanding of regulatory documentation and quality assurance practices.
- Detail-oriented with good coordination and communication skills across R&D;, QA, and Regulatory teams.

📌 Research Associate - DQA (Una)
🏢 Stanford Laboratories
📍 Una