Team Member - Quality Control

Quality Control Analyst will be responsible for performing analysis of raw materials, in-process samples, finished products, and stability samples in compliance with approved specifications, SOPs, and regulatory requirements (cGMP, USFDA, ICH). The role involves handling analytical instruments, ensuring data integrity, and maintaining documentation as per audit standards.

Perform analysis of API, excipients, in-process, finished products, and stability samples.

Execute testing using instruments such as HPLC, GC, UV-Visible Spectrophotometer, Dissolution, KF, IR, etc.

Ensure adherence to approved STPs, specifications, and SOPs.

Operate maintain analytical instruments like HPLC, GC, Dissolution apparatus, FTIR, KF, etc.

Perform routine checks, system suitability, and troubleshooting.

Required Skills:

Strong knowledge of analytical techniques (HPLC, GC, etc.)

Good understanding of cGMP, data integrity, and regulatory expectations

Familiarity with LIMS and electronic data management systems

Good documentation and communication skills

Must have experience in Empower and LIMS software.

M.Sc (Chemistry), B.Pharm

Record all raw data in notebooks / LIMS systems as per ALCOA+ principles.

Ensure proper documentation with no overwriting, no loose sheets, and traceability.

Review analytical data for accuracy and compliance.

Follow cGMP, GLP, Data Integrity (DI), and regulatory guidelines.

Assist in OOS, OOT, deviation, and incident investigations.

Support root cause analysis and implementation of CAPA.

Perform stability sample analysis and trending.

Ensure timely completion of assigned samples.