Sipra Labs Limited, a 30+ year US FDA-approved Contract Research Organization serving Pharma, Biotech and Medical Device clients, seeks an Analyst - LC-MS/MS for its Analytical Lab in Hyderabad. The role covers assay, related substances, impurity profiling and elemental/extractable support on LC-MS/MS platforms (Waters/Sciex/Agilent), method execution, calibration and system-suitability checks, and SLIMS-based reporting. The analyst will maintain raw data and logbooks per ALCOA+, support method validation/transfer, and comply with cGMP, NABL 17025 and US FDA 21 CFR 211 requirements.
Preferred candidate profile:
M.Sc. (Analytical / Organic Chemistry) or equivalent, with 3-5 years hands-on LC-MS/MS experience in a regulated CRO or pharma QC laboratory.
Compliance requirement:
This position requires strict adherence to cGMP/GLP, 21 CFR Part 11 and data integrity (ALCOA+) principles, consistent with Sipra Labs status as a US FDA-approved and NABL (ISO/IEC 17025) accredited facility. Candidates with any prior data-integrity violation at a regulated employer will not be considered.