Role & responsibilities
- Lead Quality Control operations and ensure GMP, ISO, regulatory, and QMS compliance.
- Manage BPRs, specifications, test methods, sampling plans, SOPs, and quality documentation.
- Oversee raw material, packaging, in-process, and finished product testing, including chemical analysis.
- Plan and manage stability studies, equipment validation including IQ, OQ, PQ and laboratory activities.
- Handle deviations, non-conformances, product disposition, quality risks, and CAPA support.
- Lead, train, and develop the QC team and provide cross-functional technical support.
- Support CE, FDA, ISO, customer, and regulatory audits/inspections.
- Ensure laboratory quality systems, data integrity, and documentation compliance.
- Sterilization & Microbiology Expertise
- EO, Gamma & Steam Sterilization Validation ISO 11135, ISO 11137 & ISO 17665.




- Cleanroom Qualification & Environmental Monitoring ISO 14644.
- Bio burden & Sterility Testing ISO 11737.
- BET/LAL & EO Residual – USP & ISO 10993-7:2026

Preferred candidate profile
- 7-10 years of work experience in Quality Control in medical devices manufacturing unit.
- Excellent computer skills, including MS Office
- Robust communication skills, including the ability to explain and teach methodologies
- Understanding of medical device manufacturing methods and procedures
- Approved chemist (analytical or manufacturing)
- A confident and determined approach
- Excellent organizational & time management skills
- Team player

Qualification

B.Sc./B.tech/B.Pharma degree only, masters may be preferred.

📌 Deputy QC Manager (New Delhi)
🏢 Madhu Instruments
📍 New Delhi