Jr Executive / Executive-QMS (OSD)

Role & responsibilities

Jr. Executive / Executive QA-QMS, OSD

Department: Quality Assurance Quality Management System (QA-QMS)
Location: MSN R&D

Job Purpose

To support and execute Quality Assurance and Quality Management System activities for OSD R&D operations, ensuring compliance with applicable GMP requirements, regulatory expectations, company procedures, and quality standards.

Key Responsibilities

• Review and ensure compliance of OSD R&D activities with applicable GMP, GLP, GDP and Quality Management System requirements.
• Review, prepare and maintain SOPs, specifications, protocols, reports and other quality documents related to R&D activities.
• Support document control activities, including issuance, revision, archival and retrieval of controlled documents.
• Review and coordinate change controls, deviations, incidents, CAPA and OOS/OOT investigations associated with R&D activities.
• Support risk assessments and implementation of appropriate risk mitigation measures.
• Review analytical, formulation and process development-related documents for compliance with approved procedures.
• Participate in internal audits, self-inspections and regulatory/customer audit preparation.
• Support audit observations, investigation, CAPA preparation and timely closure of quality-related actions.
• Review and monitor training records and ensure completion of applicable GMP/QMS training.
• Support Good Documentation Practices (GDP) and data integrity compliance across OSD R&D activities.
• Coordinate with Formulation R&D, Analytical R&D, Engineering, Regulatory Affairs, QC and other cross-functional teams for quality-related activities.
• Assist in preparation and review of development protocols, reports, technology transfer documents and other technical documents, as applicable.
• Monitor QMS metrics and support preparation of periodic quality reports and management-review inputs.
• Ensure timely closure of assigned quality events and action items.
• Support continuous improvement initiatives related to QMS and R&D processes.
• Perform any other QA/QMS responsibilities assigned by the reporting manager.

Key Competencies

• Good understanding of GMP and Quality Management Systems.
• Knowledge of ICH guidelines and regulatory requirements applicable to pharmaceutical R&D.
• Strong understanding of Good Documentation Practices and Data Integrity.
• Good documentation, analytical and problem-solving skills.
• Ability to review technical and quality documents critically.
• Good communication and interpersonal skills.
• Ability to coordinate effectively with cross-functional teams.
• Proficiency in MS Office (Word, Excel and PowerPoint).
• Strong attention to detail and commitment to quality.

Educational Qualification

Essential:

• B.Pharm / M.Pharm