• 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 recent 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, cleaning validation protocols and reports.
• Ensure support to regulatory function in timely submission of documents.
• Documentation:
• Ensure timely preparation, approval and effective implementation of Site Standard Operating Procedures.
• Approval of Master Formula for Drug Substance.
• Ensure timely preparation, approval and effective implementation of Quality function documents as per SOP.
• Ensure timely Annual Product Quality Review and necessary corrective action.
• Ensure timely qualification and training of personnel.
• Review and Signing of Confirmation of Compliance (CoC).
• Review and approval of Quality Risk Management study for systems, equipment, facility, utilities, material, pharmaceutical process, new API introduction in 3.




• Audit and Compliance:
• Ensure all time readiness of site for regulatory inspections, customer audits and Corporate Quality audits.
• Participation in Self audits and compliance.
• To conduct Vendor Audit and Contract Laboratories Audit as per requirement.
• Response to audit observations in consultation with all stakeholders as per the timeline mentioned in the report.
• Act as Inspection Lead (Escort) in regulatory inspections.
• Handling of external audits and co-ordination of compliance response to regulatory observations.
• Market Complaint, Recall and Returned Products:
• To aid in the investigation of customer complaint as well as and implementation of the suggested preventive actions.
• Review & approval of the customer complaint investigation report.
• Ensure timely support of USV affiliates from the site in filed alerts, recalls and product returns.
• Approval of the preliminary report for returned goods.
• Training:
• To provide training related to cGMP and quality Systems or SOP’S.
• On Job training for Quality Control and Quality Assurance personnel.
• To provide cGMP training with respect to USV quality policy and regular guidelines.
• People Development:
• Provide functional and technical guidance to the team through on the job coaching and support them in capability development.
• Team motivation and upliftment.
• Keep self and team updated to developments and advances in his field of work.

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