Technical Expertise:

- Hands-on experience with HPLC, UV, IR, GC instruments
- Robust understanding of GMP compliance
- Knowledge and adherence to Data Integrity principles (ALCOA/ALCOA+)

Audits Faced:

- Involved in facing regulatory and internal audits such as:
- USFDA / MHRA / WHO / GMP / ISO (mention whichever apply for the candidate)
- Supported audit preparedness, documentation, and CAPA implementation

Roles & Responsibilities:

- Performing routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples.
- Operation, calibration, and troubleshooting of analytical instruments (HPLC, UV, IR, GC)
- Preparation and review of analytical documents, SOPs, COAs, and test reports.
- Ensuring compliance with GMP, GLP, and data integrity requirements.
- Maintaining lab documentation as per ALCOA+ principles.
- Handling OOS, OOT, deviations, and supporting investigations.
- Participating in internal and external audits; ensuring audit readiness.
- Maintaining good housekeeping, safety, and adherence to laboratory practices.
- Coordination with cross-functional teams to ensure timely release of batches and samples

📌 Quality Control Analyst (Hyderabad)
🏢 Ritsa Pharma
📍 Hyderabad