Am/ Dm Dqa (api) Job in Alembic Pharmaceuticals Limited

Desired Profile:

• Review and approval of R&D product development reports, specifications and SOP's of API lab.
• Review and approval of analytical method development and method validation protocols & reports.
• To exercise document and data control and ensure cGMP compliance at departmental level.
• Review of vendor qualification documents and maintain the approved vendor list at R&D level.
• Knowledge of GMP, GLP and regulatory guidelines.
• Hands on experience to handle change controls, deviations, Incidents and CAPA managements.
• Review and approval of equipment qualification, validation protocols and reports.
• Hands on experience to conduct external vendor audits and compliance qualitatively for suppliers and testing labs.