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About the role
Ensure compliance with USFDA, GMP, and ISO 13485 requirements while maintaining and reviewing quality documentation and records. Support CAPA, deviation, change control, and non-conformance processes, and assist with audits, regulatory inspections, and quality system activities.
What they look for
Requirements
Requires 1–3 years of experience in the medical device or pharmaceutical industry and a relevant B.Pharm, M.Pharm, B.Sc., or M.Sc. qualification. Candidates should know USFDA regulations and QMS, and have experience with documentation, CAPA, deviations, root cause analysis, audit readiness, and regulatory compliance.
Full description
Job Description: Junior Executive – Quality Assurance (USFDA – MYVAL)
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.
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