with 2 to 4 years of experience in a regulated pharmaceutical or biopharmaceutical QC laboratory. The role involves performing analytical testing of raw materials, in-process samples, and finished products in compliance with cGMP and regulatory requirements.
Key Responsibilities:
Perform routine and non-routine analytical testing of:
Raw materials, intermediates, in-process, finished products, stability samples
Water and cleaning validation samples (if applicable)
Operate and calibrate analytical instruments such as:
HPLC, GC, UV-Vis, FTIR, Karl Fischer, pH meter, Dissolution, etc.
Prepare and review test records, logbooks, and related documentation as per GMP and data integrity standards.
Conduct analysis as per pharmacopeial methods (USP, EP, IP, JP)
Support in method validation/verification and equipment qualification activities.
Review and interpret analytical results and escalate OOS/OOT results promptly.
Maintain compliance with laboratory SOPs, GLP, and safety procedures.
Participate in stability studies, trending data, and document control activities.
Support investigations, deviations, and implementation of CAPAs related to QC analytical operations.
Participate in internal and external audits and regulatory inspections.
Qualifications:
M.Sc. (Chemistry, Analytical Chemistry, Biotechnology) / B.Pharm / M.Pharm
2 to 4 years of hands-on experience in QC Analytical in a cGMP-compliant pharmaceutical or biopharma lab
Key Skills:
Handling of oncology molecules is plus
Proficient in handling HPLC, GC, and other analytical instruments
Familiarity with
pharmacopeial testing
(USP, EP, IP)
Good understanding of
cGMP, GLP
, and data integrity practices
Strong documentation and observation skills
Working knowledge of LIMS or electronic data systems is an advantage
Job Type: Full-time
Pay: ?11,407.45 - ?27,703.75 per month
Benefits:
Provident Fund
Experience:
Laboratory: 3 years (Required)
Clinical laboratory: 3 years (Required)
Laboratory procedures: 3 years (Required)
Laboratory techniques: 3 years (Required)
Work Location: In person
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