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.

Qualifications :

(Chemistry)

Additional Information :

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

Remote Work :

No

Employment Type :

Full-time