Sipra Labs Limited - a US FDA-approved Contract Research Organisation with over 30 years of service to the Pharmaceutical, Biotech and Medical Device industries - invites applications for Analyst / Sr. Analyst - LCMS in its Analytical Division, Hyderabad.

Key Responsibilities

- Perform trace-level analysis by LC-MS/MS (triple quadrupole / HRMS) for nitrosamines, genotoxic and mutagenic impurities, trace impurities and extractables/leachables on APIs, excipients and finished products as per approved methods, pharmacopoeial requirements (USP 1469, ICH M7, EMA/US FDA nitrosamine guidance) and client protocols.
- Carry out sample preparation, standard preparation and calibration; optimise MS source and MRM parameters.
- Execute method development, validation, verification and transfer studies (ICH Q2(R2), USP General Chapters 1225 and 1226).
- Operate, calibrate and maintain LCMS systems; maintain instrument logbooks, tuning records and system suitability.




- Record data contemporaneously in laboratory notebooks and LIMS in line with ALCOA plus and 21 CFR Part 11; review audit trails.
- Raise deviations, OOS/OOT and CAPA where required; adhere to cGMP, SOPs, EHS and data-integrity requirements; support US FDA, NABL and client audits.
- Sr. Analyst: additionally review peer data, lead method development projects and mentor analysts.

Preferred Candidate Profile

- M.Sc (Chemistry / Analytical Chemistry) / B.Pharm / M.Pharm.
- 3-8 years hands-on LC-MS/MS experience in a GMP-regulated pharma QC or CRO laboratory (mandatory). Nitrosamine / GTI analysis experience preferred.
- Working knowledge of ICH, USP, EP and IP, cGMP and data-integrity principles.
- Immediate joiners / up to 30 days notice preferred.

Interview: Walk-in, Sipra Labs Limited, Sanathnagar, Hyderabad. Contact: Ms Revathi P - (phone hidden). Carry resume, original certificates, last 3 months payslips and photo ID.

Talent Acquisition, Sipra Labs Limited

📌 Analyst / Sr. Analyst - LCMS (Hyderabad)
🏢 SIPRA LABS
📍 Hyderabad