Manager - CMO Corporate Quality

Role : CMO Corporate Quality

Grade : Manager

Job Summary:

• To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities' requirements are met and that all SUN affiliates, CMO, Suppliers and SUN sites / Operational Units to achieve, maintain and improve the adequate level of compliance, through "Quality Oversight" and "Independent auditing and Follow-up".

Essential Job Functions:

• Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
• Oversee and approve Quality Management System (QMS) elements reported by CMOs, including change control, deviations, incidents, Out of Specification (OOS)/Out of Trend (OOT) results, and complaint investigations.
• Review and approve master documents from CMOs, such as Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), specifications, validation protocols, and stability protocols.
• Provide support during regulatory audits at CMO sites related to SUN Pharma product approvals.
• Engage in critical investigations at CMO sites, including OOS results, deviations, and complaints.
• Review and maintain quality agreements with CMOs to ensure compliance and quality standards.
• Initiate QMS documents in the Trackwise system, inform the respective CMO, and track to ensure closure of initiated QMS elements.
• Monitor and oversee activities carried out at CMO sites to ensure compliance with SUN Pharma standards.
• Review executed documents from CMOs related to SUN Product to ensure accuracy and compliance.
• Perform batch release of SUN products manufactured at CMO sites, ensuring they meet quality standards. Make appropriate transition related to batch releases in SAP system.
• Coordination with the Sun Pharma warehouse for market releases of batches, including investigating temperature excursion reports during finished product transport and addressing physical damages reported by the warehouse in finished product consignments. Conduct regular visits to CMO sites, prepare detailed visit reports, and follow up on any issues identified.
• Review and approval of printed packaging artwork.
• Review and approval of formulation orders and packaging orders, followed by master recipe approval.
• Involvement as quality oversight during product transfer activities.
• Support for the project management team during the execution of exhibit/scale-up batches at the CMO site.
• Preparation and review of the approved vendor list for materials supplied to the CMO site by Sun Pharma.
• Involvement in management notifications, batch failure investigations, and recall management.
• Support during annual submissions to the Sun Pharma regulatory department.
• Involvement in the preparation of annual schedules, annual product reviews, and quality agreements. To conduct thorough GMP Audit at Vendors (manufacturers), Raw Materials, Excipients, and Packaging Materials to SUN Pharma to ensure that they always deliver high quality and standard products and remain compliant with GMP requirements.
• To co-ordinate with Vendor for desired documents for pre-audit preparation, logistics, resource, so as to execute successful audit as per schedule.
• To outline and circulate audit agenda prior to audit. The Audit Agenda shall be prepared based on reason behind conducting GMP audit, e.g. Qualification, Surveillance or For-Cause Audit.
• To execute on-site audit through facility visit and review of quality management systems established in various functions such as Material Management, Production & Packing, Facility & Equipment, Quality Systems and Quality Control Laboratory, including microbiology lab, as applicable.
• To makes sure that, SUN Manufacturing Sites, Contract Manufacturing Organisations, and Affiliate Companies are prepared for Regulatory Agency Inspections e.g. through "Mock" inspections, audits and supports activities whenever required.
• To ensure during audit that, non-compliances to the requirements stated in various guidelines have been identified.
• To communicate the outcome of CMO Audit, based on the risk associated with the patient, regulatory compliance and business risk, to facilitate making decision of Vendor Approval / Dis-approval.
• To prepare Planner, Schedule, Audit Report, including non-compliances and review compliance reports thereof to close the audit. This includes performing routine follow up of performed audits to ensure timely compliance and closure of the audit.
• To review & approved the audit report, closure, as applicable.
• To maintain evidences and documents related to audit.
• To prepare Monthly report and to highlight the key area of concerns.
• To participate in the trainings to update on current / upcoming regulations.
• To follow the Corporate Quality Policies/ Global Quality Standards (GQS) and applicable Regulatory Guidelines.
• Participate and execute the project work as allotted by reporting authority.
• To perform the risk assessment.

Basic Qualification:

• B. Pharmacy & M. Pharmacy

Experience : 12 to 15 Yrs ( Work Experience of CMO and US market required Sterile Background)