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).
- Robust attention to detail and commitment to quality.

Educational Qualification

Essential:

- B.Pharm / M.Pharm

📌 Jr Executive / Executive-QMS (OSD) (Hyderabad)
🏢 MSN Group
📍 Hyderabad