Auditing all kind of pharmaceutical suppliers across Asia-pacific region

- To define Systems, Standards and Procedures to be followed.- To verify implementation of systems / procedure.- To ensure release of batches based on the review of batch documents and quality control reports.- To comply with company policies, procedures, quality standards to achieve quality goals.- To monitor compliance with the requirements of current Good Manufacturing Practice and also to conduct management review meeting.- To ensure that required initial and continuing training of personnel is carried out and adopted according to the need.- To have co-ordination with R&D, Production, Quality Control, Engineering and Stores department for improving various quality concerned aspects.- To co-ordinate in completion of validation and qualification activities for all equipments, instruments and facility.- To identify, audit, approve and monitor material suppliers, service providers and contract analysts.- To plan and conduct internal audits, initiate and approve the corrective action plans.- To approve change control, deviations, CAPAs, Batch documents. - To approve process and validation / qualification documents, MPCR, BPCR, written procedures, specifications, test procedures and other documents including amendments.- To approve or reject intermediate, bulk and finished products.- To take decisions for rejecting starting and packing materials in case of failure in test results.- To check and approve SOPs of all departments.- To review and update Master documents like VMP, SMF and organogram.- To coordinate for various audits, Regulatory and customer.

- Understanding of regulatory guidelines and development of company's Procedures and workflow elements in compliance with various quality system requirements.- Develop audit plan and conduct audits of processes, systems and studies to ensure compliance with applicable regulatory requirements and Standard Operating Procedures- Track timelines, milestones and other requirements for projects and audits undertaken by department Ensure that projects are delivered by the department as per timelines.

- Control (Issuance, Review, Distribution, etc.) of SOPs, Batch Production Records, Forms, Log Books.- Monitoring of Calibration and Preventive maintenance activities of the Instruments and equipments as QA team member.- Review of the Batch Production Records, in-process and finished product analysis data and monitoring of dispatch of the active pharmaceutical ingredients as per the customer requirements.