Alesha Walker

Similar Profiles

• Fareeha RizviFareeha Rizvi

  Technical Writer and Engineering Analyst at AbbottTechnical Writer and Engineering Analyst at Abbott

• John GoodrichJohn Goodrich

  Service Writer at LaFontaine Chevrolet Buick GMCService Writer at LaFontaine Chevrolet Buick GMC

• Indira PenemetchaIndira Penemetcha

  <ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health<ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health

• Rohit RathorRohit Rathor

  <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. 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