Analyst - HPLC

Sipra Labs Limited; Hyderabad; On-site; INR 400,000 - 600,000; Full time

Job summary

Sipra Labs Limited invites applications for Analyst - HPLC in its Analytical Division, Hyderabad. The role focuses on performing HPLC/UPLC analyses in GMP-regulated QC/CRO settings, adhering to ICH/USP guidelines and data integrity standards.

Selected candidates should have 2–5 years hands-on HPLC experience, M.Sc in Chemistry or B.Pharm/M.Pharm, and be prepared to join promptly. Training on client protocols and audits will be provided.

Qualifications

• MSc/ BPharm/ MPharm in relevant fields with specialisation in Analytical Chemistry.
• 2–5 years hands-on HPLC experience in GMP-regulated pharma QC or CRO lab.
• Working knowledge of ICH, USP, EP, and data-integrity principles.

Responsibilities

• Perform assay, related substances, dissolution and stability testing by HPLC/UPLC.
• Execute method validation, verification and transfer studies (ICH Q2(R2)).
• Prepare standards, mobile phases and samples; operate HPLC/UPLC and CDS.
• Record data in notebooks and LIMS per ALCOA+ and 21 CFR Part 11.
• Conduct instrument calibration checks; raise deviations and CAPA as needed.
• Adhere to cGMP, SOPs, EHS and support audits.

Skills

HPLC

UPLC

GMP QC

Data integrity

ICH guidelines

cGMP

Education

M.Sc (Chemistry / Analytical Chemistry)

B.Pharm / M.Pharm

Tools

Waters HPLC

Agilent HPLC

Shimadzu HPLC

Empower/LabSolutions

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 - 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.