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

Am/ Dm Dqa (api)

Alembic Pharmaceuticals Limited 4+ weeks ago

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Job Summary

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.

Qualification :
M.Sc./ M. Pharm/ B. Pharm

Experience Required :

8 to 12 Years

Vacancy :

2 - 4 Hires

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