07 Aug
|
Ritsa Pharma
|
Hyderabad
07 Aug
Ritsa Pharma
Hyderabad
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 valuable 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