Team Member - Quality Control
On-site · Hyderabad, Telangana, India
Job Summary
Team Member - Quality Control responsible for performing analysis of raw materials, in-process samples, finished products, and stability samples in compliance with approved specifications and regulatory requirements. Use analytical instruments such as HPLC, GC, UV-Visible spectrophotometer, Dissolution, KF, IR, FTIR, etc.; ensure data integrity and proper documentation per audit standards; perform routine system checks and troubleshooting. Execute stability sample analysis and trending, assist in OOS/OOT/deviation investigations, support root cause analysis and CAPA implementation. Requires strong knowledge of analytical techniques (HPLC, GC, etc.), familiarity with LIMS/ Empower software, and adherence to cGMP, DI, and regulatory guidelines. Educational requirement includes M.Sc (Chemistry) or B.Pharm, with experience in ALCOA+ documentation and regulatory compliance.
Required Qualifications
- M.Sc (Chemistry) OR B.Pharm OR equivalent
- Experience with analytical instruments (HPLC, GC, UV-Vis, etc.) and data management
- Knowledge of cGMP, GLP, DI and regulatory guidelines
- Experience with Empower and LIMS software
- Strong documentation and communication skills
- Record keeping in ALCOA+ principles
- Perform stability and trend analysis
- OOS/OOT and deviation investigations
- CAPA implementation
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