Technical Services - Pudupakkam, India - Endo

Description

Review of ANDA packaging details filed for launch products and review of packing equipment and packing materials availability for new launch products or site transfer products
Due diligence of product and evaluation of pack suitability for the launches and proposal of any changes if required from initial development or during the site transfer.
Packing strategy finalization and developing alternate strategies with strong scientific rationale for submission/ validation batches packaging.
Design of change parts for appropriate packaging machine for validation batches.
Review and approval of artworks and packaging materials specifications.

Review of ANDA packaging details filed for launch products and review of packing equipment and packing materials availability for new launch products or site transfer products

Due diligence of product and evaluation of pack suitability for the launches and proposal of any changes if required from initial development or during the site transfer.

Packing strategy finalization and developing alternate strategies with strong scientific rationale for submission/ validation batches packaging.

Design of change parts for appropriate packaging machine for validation batches.

Review and approval of artworks and packaging materials specifications.

Audit compliance. Ensuring cGMP at site level. Risk evaluation for Nitrosamine impurities.

Following and implementing the endo values during day-to-day activities.

Awareness of EHS policy, significant environment aspect & impacts associated with workplace and Contribution to environment management system. Supporting to the Cross functional team during Audit and Performing Internal Audits (Qualified Auditor). Responsible to follow and ensure the procedures pertaining to the environmental management system. Responsible to keep the workplace neat and clean.