- Performing Stability analysis, Method transfer and Method Validation.
- Preparation and review of Method Transfer Protocols, Validation protocols and all related protocols, procedures and reports.
- To carry out analytical method development, method validation and testing of impurities in finished products on LCMS/MS and GCMS/MS
- Performing calibration for GCMSMS, LCMSMS system, micropipettes and performing the In-House Preventive maintenance of GCMSMS and LCMSMS
- Preparation, review of departmental SOP's and training of analysts.
- Calibration and validation of instruments / equipments.
- Review and maintenance of all logbooks in the department.
- Procurement of columns, chemicals/ reagents/ solvents and standards for Stability analysis, Method Transfer and Method Validation.
- Detailed description of MAIN tasks and responsibilities:
- Preparation and review of Method Transfer Protocols, Standard Testing Procedure, Test Data Sheet for Stability Analysis, Method transfer and Method Validation, Stability Summary Reports and any document related to stability analysis, method transfer and method validation in compliance with current guidelines. Review and maintenance of all logbooks of the department
- Preparation of departmental SOP's in compliance with current guidelines. Review of departmental SOP's, training of analysts and other technical staff and review validation of data transfer, data management using computer systems.
- Preparation and review of validation protocols in compliance with current guidelines.
- MSc / B Pharm, M Pharm with 08-10 years of Experience.
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Quality Control Analyst II - Chennai, India - Teva Pharmaceuticals
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Description
Who we are
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.How you'll spend your day
Your experience and qualifications