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 - HPLC in its Analytical Division, Hyderabad.
Key Responsibilities
- Perform assay, related substances, dissolution and stability testing by HPLC and UPLC as per approved methods, pharmacopoeial monographs and client protocols.
- Execute method validation, verification and transfer studies (ICH Q2(R2), USP General Chapters 1225 and 1226).
- Prepare standards, mobile phases and samples; operate and maintain HPLC systems (Waters/Agilent/Shimadzu) and CDS (Empower/LabSolutions).
- Record data contemporaneously in laboratory notebooks and LIMS in line with ALCOA plus and 21 CFR Part 11; review audit trails.
- Perform instrument calibration checks, column logs and system suitability; raise deviations,
OOS/OOT and CAPA where required.
- Adhere to cGMP, SOPs, EHS and data-integrity requirements; support US FDA, NABL and client audits.
Preferred Candidate Profile
- M.Sc (Chemistry / Analytical Chemistry) / B.Pharm / M.Pharm.
- 2-5 years hands-on HPLC experience in a GMP-regulated pharma QC or CRO laboratory (mandatory).
- 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.