Analyst / Sr. Analyst - LCMS

Sipra Labs Limited; Hyderabad; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Sipra Labs Limited in Hyderabad invites applications for Analyst / Sr. Analyst - LCMS in its Analytical Division. The role involves trace-level LC-MS/MS analysis, method development, validation, transfer, and ensuring regulatory compliance under cGMP and data integrity standards.

Ideal candidates have 3–8 years hands-on LC-MS/MS experience in GMP pharma QC or CRO labs, with nitrosamine analysis exposure; immediate joiners preferred. Joiners will mentor analysts and support audits.

Qualifications

• 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.

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.

Skills

LC-MS/MS

GMP knowledge

Nitrosamine analysis

Data integrity

Audits

Education

M.Sc (Chemistry / Analytical Chemistry)

B.Pharm

M.Pharm

Tools

LIMS

Job description

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.