Analyst - QC

Name of the Company – Zydus
Healthcare Limited
Industry –
Pharmaceuticals
Website of the
company - https://www.zyduslife.com/zyduslife/
Location –Sikkim Unit
I & Unit II
Position -
Officer / Executive
Qualification – M.Sc. / B.Sc. in Chemistry, Microbiology
& Biotechnology
Experience Required –
Between 1 to 4 Years Of Experience
Role – QC Analyst
No’s of Vacancy - 5
Key Responsibilities
Perform analysis of Raw
Materials (RM), Finished Products (FP), Stability Samples, Water Samples,
and Microbiological Samples as per approved specifications and test
methods.
Conduct testing using HPLC,
GC, UV-Visible Spectrophotometer, FTIR, Dissolution, and other analytical
instruments.
Perform microbiological
testing including Environmental Monitoring, Water Testing, Bioburden, and
Microbial Limit Testing.
Monitor stability studies
and perform testing as per approved stability protocols and ICH guidelines.
Prepare and standardize
reagents, volumetric solutions, culture media, and reference standards.
Review analytical and
microbiological data and ensure compliance with established
specifications.
Maintain laboratory records,
logbooks, worksheets, analytical reports, and documentation as per GMP and
GLP requirements.
Investigate OOS, OOT,
laboratory incidents, and microbiological deviations.
Ensure compliance with GMP,
GLP, Data Integrity, and Safety requirements.
Support method validation,
method transfer, instrument qualification, and calibration activities.
Participate in internal
audits, regulatory inspections, and compliance-related activities.
Coordinate with QA,
Production, Engineering, and Regulatory Affairs for laboratory-related
activities.
Ensure proper maintenance,
calibration, and operation of laboratory instruments and equipment.
Required Skills
Hands-on experience with
HPLC, GC, UV, FTIR, Dissolution, and other analytical instruments.
Knowledge of microbiological
testing, Environmental Monitoring, and Water Analysis.
Understanding of GMP, GLP,
Data Integrity, and laboratory compliance requirements.
Knowledge of pharmacopeial
requirements including IP, USP, BP, and EP.
Familiarity with OOS, OOT,
CAPA, Deviation, Change Control, and QMS processes.
Strong analytical,
troubleshooting, documentation, and communication skills.
Proficiency in laboratory
documentation and data review practices.
Preferred Experience
Experience in pharmaceutical
Quality Control laboratories handling RM, FP, Stability, and Microbiology
activities.
Exposure to regulatory
audits and GMP-compliant laboratory operations.
Experience in analytical
method validation, stability studies, and microbiological testing.
Knowledge of laboratory
software, chromatography data systems, and electronic documentation
practices.
Hands-on experience with
regulated manufacturing environments and quality systems.
Interested candidates may share their CV at Bishnu.M.Bhujel@zyduslife.com

Experience
1 - 4 Years

Employment type
P-P7-Probationer-HO Staff

Work arrangement
No