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.
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.
B.Pharm / M.Pharm / BSc / MSc; Lactose India Limited is a young and innovative company specializing in the manufacturing of Excipients Lactose / Colour Coatings, Lactulose, Solid Dosage Forms, Liquid Dosage Forms, at Vadodara, Gujarat.
To conduct the CAPA effectiveness review activities at manufacturing sites of Sun Pharma as per the review plan. To perform CAPA effectiveness review for CAPAs provided to Regulatory Authorities.
This role is responsible for managing and overseeing critical aspects of the production process, ensuring adherence to quality standards and regulatory compliance.