Senior Executive, Analytical R&D (Validation) Injectable

Description:

The role involves operating advanced analytical instruments like HPLC, GC, ICP-MS, for testing raw materials, finished products, and dosage forms. The position requires ensuring compliance with good laboratory practices, performing data analysis, and maintaining accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, and conducting method transfers, all while supporting the lab's continuous development through training and adherence to SOP

Essential Functions:

• Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc.
• Prepare method development report along with tentative analytical method.
• Attain method transfer activity.
• Method validation like Dissolution, Assay, Related compound and Residual solvents etc.
• Preparation TT report
• To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory.
• Preparation of study protocols with respect to Laboratory.
• Development batch stability analysis as per stability protocols
• To attain and complete self-training through QMS.
• Responsible for COA preparation and release of development sample against TRF.
  Additional Responsibilities:
• Raise indents, prepare Capex, and manage laboratory inventory.
• Taking responsibility to give training to junior for on job training
• Attend technical workshop /seminar and explore new technique and technology at work place

Education:

• Bachelors Degree (BA/BS) B. Sc - Required
• Bachelors Degree (BA/BS) B. Pharma - Preferred
• Master Degree (MS/MA) M. Sc - Preferred
• Master Degree (MS/MA) M. Pharma - Preferred

Experience:

• 5 years or more in 5-7 years

Skills:

• Documentation & Data Review, Interpretation & Statistical Analysis - Intermediate
• Anlytical Method Development & Validation - Intermediate
• Good Laboratory Practices (GLP), Data Integrity and Compliance - Advanced
• Stability Study Management - Advanced
• Good Documentation Practices (GDP) - Intermediate
• Electronic Lab Notebook (ELN) Management/LIMS - Advanced
• Adapts to organizational growth - Intermediate