Role & responsibilities:

- Oversee QC operations for raw materials, in-process, finished products, and stability studies
- Ensure compliance with cGMP, GLP, ISO 13485, and regulatory guidelines
- Manage and review analytical testing (HPLC, GC, UV, dissolution, etc.)
- Handle QMS activities CAPA, deviation, OOS/OOT, change control
- Ensure audit readiness and support internal, customer, and regulatory audits
- Monitor and maintain instrument calibration, validation, and qualification
- Oversee stability program (real-time, accelerated, trending, reporting)
- Lead and train QC team; allocate work and ensure timely execution
- Coordinate with QA, production, and regulatory teams for smooth operations
- Ensure data integrity (ALCOA+) and proper documentation practices
- Drive continuous improvement in QC processes and compliance systems

Preferred candidate profile





- 9-13 Years of experience in Quality Control experience in IVD, Diagnostics, Medical Devices, Biotechnology, or Life Sciences industries.
- Valuable experience in QC laboratory operations, including raw material, in-process, finished product, and stability testing.
- Hands-on experience with ISO 13485, GMP/GLP, CAPA, OOS/OOT investigations, deviations, change control, and data integrity
- Exposure to regulatory audits and inspections, with the ability to maintain audit readiness and ensure compliance.
- Proven team leadership and cross-functional coordination experience, managing QC teams and collaborating with QA, Manufacturing, R&D;, and Regulatory Affairs.

📌 Qc Manager (Hyderabad)
🏢 Advy Chemical
📍 Hyderabad