Experience: 1–3 years in the Medical Device/Pharmaceutical industry
Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc. in a relevant discipline
Key Responsibilities:
- Ensure compliance with USFDA, GMP, and ISO 13485 requirements.
- Maintain and review quality documentation and records.
- Support CAPA, deviation, change control, and non-conformance management.
- Assist in internal audits, regulatory inspections, and quality system activities.
- Ensure adherence to SOPs and quality standards.
Requirements
Key Skills:
- Knowledge of USFDA regulations and Quality Management Systems (QMS).
- Documentation and record management.
- CAPA, deviation handling, and root cause analysis.
- Audit readiness and regulatory compliance.
- Attention to detail and effective communication.