QC Analyst Full Time

Technical Expertise:

• Hands-on experience with HPLC, UV, IR, GC instruments
• Strong 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.