Quality Control Analyst
4 days ago
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.
-
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