Key Responsibilities:
- Support the implementation and maintenance of Quality Management Systems (QMS) in accordance with applicable standards such as ISO 13485 and regulatory requirements.
- Assist in the review, preparation, and maintenance of quality documentation, including SOPs, work instructions, quality manuals, and records as part of ongoing AMC support for clients.
- Coordinate with cross-functional teams and client representatives to collect documentation and ensure effective implementation of quality system requirements.
- Support the maintenance and control of QMS processes, including document control, training records, CAPA, complaint handling, and change management.
- Assist in preparing organizations for certification audits, surveillance audits, and regulatory inspections by ensuring documentation readiness and compliance with applicable standards.
- Monitor updates in quality standards and regulatory requirements, and support the implementation of necessary changes within client quality systems.
- Provide guidance to internal teams and clients on quality system requirements and best practices to ensure continuous compliance and improvement.
Qualifications & Skills:
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Quality Management, or a related field.
- Minimum 6 months of experience in Quality Assurance or Quality Management Systems.
- Basic understanding of ISO 13485 Quality Management System requirements.
- Familiarity with QMS processes such as CAPA, internal audits, document control, training management, and risk management.
- Strong documentation, analytical, and problem-solving skills.
- Excellent communication and coordination skills to work effectively with internal teams and clients.
- Ability to manage multiple projects, prioritize tasks, and meet deadlines in a dynamic regulatory environment.
Job Type: Full-time
Pay: ₹25,000.00 - ₹35,000.00 per month
Benefits:
- Flexible schedule
- Health insurance
- Provident Fund
Work Location: In person
