Zakir Hussain

Senior Quality Assurance Manager External Supply Operations @Sandoz

Hyderabad, IN

Calibrated quality oversight of external manufacturing sites (CMO) for Sterile/Oncology/Solid oral/GCC formulations as per established policies and procedures of the Division and Corporation and complies with all applicable governmental regulations /GMP etc. • Managing the development and maintenance of a quality assurance agreement with the CMO’s• Adhering to quality risk assessment /management and data integrity assessment at assigned CMO’s as well as continuous training imparted during routine quality oversight• Ensuring permanent audit readiness, and support in effective QMS at assigned CMO’s as well as all the APQR’s, change controls, Deviations, OOS, market/quality complaints, quality alerts, FAR, recalls etc. are being handled in timely manner and are reported in the electronic systems as per requirements.• Supporting CMOs during analytical and process validation of new products• Maintaining strong relationship with assigned CMO’s and other stakeholders for communication and escalation of issues.• Developing & implementing the Quality Department’s strategy, to ensure it meets business requirements and customer deliverables; ensuring departmental performance against set goals• Facilitating alignment of departmental objectives and activities with quality system & strategic objectives • Establishing effective audit programs; managing all validation activities, including validation strategy & approval of protocols• ERP/SAP updation for supplier management.• Closely collaborates with appropriate business and operations areas, stakeholders like Global Quality service centers, MS & T, Development centers, Regulatory and supply to ensure no stock out due to quality issues.

Osmania University

Bachelor of Science - BS

Doctor Babasaheb Ambedkar Marathwada University

M.Sc