Responsible for developing, executing, and documenting qualification and validation protocols for equipment, utilities, and facilities in a regulated pharma setup.
Manage granulation, compression, coating, palletization and capsule filling area. Ensure compliance with SOPs, cGMP and regulatory standards. Maintain accurate documentation and support continuous improvement initiatives.
Lead strategic planning and execution of CMO operations aligned with business goals. Oversee end- to-end supply chain coordination, including demand and material planning, ensuring timely production and delivery.
Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.