Namratha Kashiwale

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  <ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. 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• Bawinile NhlabatsiBawinile Nhlabatsi

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Identify potential areas of compliance vulnerability and risk; assists with the development of corrective action plans for the resolution of problematic issues; and provides general guidance on how to avoid or deal with similar issues in the future</li><li>Conduct on-site financial compliance reviews which include: cash counts; review of accounts receivables including employee receivables; documentation of segregation of duties and internal control structure; document storage and retention</li><li>Document findings, propose improvements or change as relevant, disseminate findings and ensure follow up implementation of recommendations as well as resolution</li><li>Conduct random surprise checks and vendor verification reviews to ensure proper procurement procedures are being practiced and report on findings</li><li>Develops an effective Compliance & Ethics training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers</li><li>Assists with improving the awareness and understanding of compliance to assist employees with the establishment of a “culture of compliance”</li></ul> at Elizabeth Glaser Pediatric Aids Foundation<ul><li>Assist in preparing Subs Annual Budgets and reviewing Subs financial reports.</li><li>Provide support and training to partners to ensure adequate support for the program component.</li><li>Conduct partner technical supportive supervision on request basis from Grants & Compliance teams.</li><li>Coordinate grantee proposal review process and ensure compliance with solicitations and donor regulations.</li><li>Coordinate pre-award evaluations and assessments of potential grantees as needed.</li><li>Analyze, verify and review grantees proposal budgets to ensure donor compliance and reasonableness.</li><li>Coordinate the assessment of grantee risk and implement appropriate systems and agreements to minimize risk.</li><li>Ensure timely and appropriate close-out of sub-grants and coordinate the close-out of EGPAF prime grants.</li><li>Provide support and training to partners finance staff to build financial and accounting capacity to ensure adequate support for the program component.</li><li>Monitor partners’ spending patterns as part of the overall project budget to actual analytics.</li><li>Follow up on Grantee monthly invoices & supporting documents</li><li>Serve as an expert on applicable policies, procedures, rules, and regulations and assist staff with their interpretation and understanding of these.</li><li>Stays abreast of donor policies, procedures, rules and regulations and host country legal requirements and informs local and regional management of significant changes.</li><li>Perform internal departmental/grants reviews ensuring compliance with Foundation and donor requirements. Identify potential areas of compliance vulnerability and risk; assists with the development of corrective action plans for the resolution of problematic issues; and provides general guidance on how to avoid or deal with similar issues in the future</li><li>Conduct on-site financial compliance reviews which include: cash counts; review of accounts receivables including employee receivables; documentation of segregation of duties and internal control structure; document storage and retention</li><li>Document findings, propose improvements or change as relevant, disseminate findings and ensure follow up implementation of recommendations as well as resolution</li><li>Conduct random surprise checks and vendor verification reviews to ensure proper procurement procedures are being practiced and report on findings</li><li>Develops an effective Compliance & Ethics training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers</li><li>Assists with improving the awareness and understanding of compliance to assist employees with the establishment of a “culture of compliance”</li></ul> at Elizabeth Glaser Pediatric Aids Foundation