Manager

To perform vendor management activity to assure that vendors are complying with Cadila procedure on vendor management and GMP requirements in order to source quality materials and products. To perform self-inspection activity to assure that the facility remains in the state of cGMP compliance, to evaluate and identify gaps for future needs and to regularly review the effectiveness and applicability of the quality assurance system. Responsible to assist for handing of day to day activities related to Vendor Approval. To assist for evaluation of vendor documents and maintain current status. To assist for preparing vendor grading of RM/PM based on rejection of supply from vendors on yearly basis. To assist for providing required documents of vendor to cross functional team. To assist for transfer of RM/PM stock in SAP, due to on-line rejection. To assist for submission of the vendor samples to QC and maintain log of Sample Register. To assist for intimation of RM/PM rejection to purchase department for CAPA and maintenance of RM/PM rejection tracking Sheet. Responsible to assist for create & update of Raw Material & Packing Material vendors in SAP. To perform vendor audits for vendor qualification as per requirement of RM/PM. To maintain quality agreements with manufacturers and contract manufacturing parties. To prepare and review of Site Master File and Quality Manual. To prepare and review of excipients risk assessments. To initiate Change Control, Deviation and CAPA as and when required. To co-ordinate and perform the Self-inspection activity at the Site. To prepare auditors list for self-inspection activity and conduct training program for auditors. To prepare audit report, review compliance report, logbook updation, follow-up for the CAPA and to ensure effective implementation of CAPA. Preparation, Review, Issuance, Revision, Control and Retrieval of SOP pertaining to functioning of the department. Participation in GMP Audits (Audit Checklist Compilation, Compliance Report Preparation etc.), to co-ordinate the Self-inspection activity, Quality Risk Assessment, implementation of Serialization applicable to all manufacturing block, to investigate Market Complaints & Deviations with cross-functional team. Responsible for any other jobs assigned from time to time. Responsible for review and approval of MMD II in system. Involve in packaging material QC activities like specimen approvals. Involve in handling of vendor complaint and ensuring timely CAPA from vendor end.