04 Aug
|
Theragen Lifesciences
|
Tamil Nadu
04 Aug
Theragen Lifesciences
Tamil Nadu
Role & responsibilities:
Perform method development, validation, and routine analytical testing for APIs and formulations.
Operate, calibrate, and troubleshoot HPLC, UHPLC, and GC instruments independently.
Ensure all analytical activities comply with GMP, GLP, and relevant regulatory guidelines.
Prepare, review, and maintain analytical documents, including protocols, reports, and SOPs.
Critically evaluate analytical results, identify deviations, and implement effective corrective actions.
Support formulation, QA, and regulatory teams during development and dossier submission stages.
Maintain data integrity and documentation as per regulatory expectations (USFDA, EMA, MHRA, etc.).
Participate in internal and external audits and contribute to continuous improvement initiatives.
Preferred candidate profile:
Hands-on expertise in HPLC, UHPLC, and GC operation and troubleshooting.
Robust understanding of analytical chemistry principles and method development.
Sound knowledge of GMP/GLP and compliance requirements for regulated markets (US &Europe;).
Ability to analyze complex data, solve problems, and design experiments independently.
Excellent communication, documentation, and report-writing skills
📌 Senior Executive Tamil Nadu
🏢 Theragen Lifesciences
📍 Tamil Nadu