Research Associate

Job Description 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. - Strong understanding of regulatory documentation and quality assurance practices. - Detail-oriented with good coordination and communication skills across R&D, QA, and Regulatory teams.