• Quality Management System / Quality Control / Quality Assurance :
• Overall responsible for Quality Control, Quality Assurance and Quality Management system.
• Verify and monitor all the activities Quality Control and Quality Assurance department and ensure smooth functioning of the department.
• Ensure that the products manufactured at the site are meeting approved standard specification and manufactured with respect to approved batch records.
• Ensure effective implementation of USV Quality Policy and EHS policy at site.
• Ensure CAPA’s identified through root cause analysis are implemented.
• Ensure market complaint, out of trend, OOS and incidents investigation done effectively and timely approved.
• Decision making while batch disposition of rejected batch /material.
• To escalate critical information or issues related safety, identity, strength, purity and quality of drug product to Head CQA.
• To present the quality data and critical quality issues during Site Quality Review Committee and Corporate Quality Review Committee meeting.




• Ensure current product launches (Exhibit and Commercial) are supported for timely launch in market.
• Ensure stability study conducted as per approved protocols and testing is executed as per defined time intervals/period defined in procedures.
• Ensure appropriate facilities and resources are available for smooth functioning of Quality function.
• Ensure smooth functioning of SAP and LIMS.
• Ensure goal setting and performance appraisal of team.
• To recruit and retain technical staff in Quality function.
• To propose and review revenue and capital budget for Quality function.
• Review and approval of QMS (Deviations, incidents, OOS, OOT, Change controls)
• Approval of QMS related activities.
• To select members for Site Data Integrity champions team.
• Facility up gradation and Quality system up gradation.
• Approval of all CSV related documents, Qualification documents and URS.
• Review and approval of process validation, cleani

📌 DGM / GM - Quality (DS Biologics) (India)
🏢 USV Private
📍 India