Cindy Gutierrez

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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. 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

• THOMAS QUALLSTHOMAS QUALLS

  <ul> <li>Tack-welded, clamped, and bolted parts to achieve desired specifications for slingshots and Rangers.</li> <li>Analyzed parts for defects and made necessary repairs before sending parts to be inspected.</li> <li>Trainer for welding processes for engine manufacturing.</li> <li>Applied shielded metal arc welding techniques with electrodes in flat, horizontal vertical positions as well as overhead applications.</li> <li>Performed preventative maintenance on welding tools and equipment.</li> <li>Inspected incoming raw materials for non-conforming items and notified suppliers of any discrepancies.</li> <li>Verified proper labeling, packaging, shipping and receiving documentation prior to releasing products from the facility.</li> <li>Replaced defective components or parts as needed.</li> <li>Reviewed technical manuals and other documents related to product operation and maintenance requirements.</li> <li>Tested assembled items with appropriate equipment to ensure proper functioning.</li> <li>Operated a variety of hand tools including drills, saws, grinders, and riveters.</li> <li>Inspected welds for accuracy, strength, and adherence to safety standards.</li> <li>Dismantled defective assemblies using hand tools, power tools, hoists, cranes.</li> <li>Utilized thermal cutting tools including oxy-acetylene torches to cut metal components prior to welding repairs.</li> </ul> at Polaris<ul> <li>Tack-welded, clamped, and bolted parts to achieve desired specifications for slingshots and Rangers.</li> <li>Analyzed parts for defects and made necessary repairs before sending parts to be inspected.</li> <li>Trainer for welding processes for engine manufacturing.</li> <li>Applied shielded metal arc welding techniques with electrodes in flat, horizontal vertical positions as well as overhead applications.</li> <li>Performed preventative maintenance on welding tools and equipment.</li> <li>Inspected incoming raw materials for non-conforming items and notified suppliers of any discrepancies.</li> <li>Verified proper labeling, packaging, shipping and receiving documentation prior to releasing products from the facility.</li> <li>Replaced defective components or parts as needed.</li> <li>Reviewed technical manuals and other documents related to product operation and maintenance requirements.</li> <li>Tested assembled items with appropriate equipment to ensure proper functioning.</li> <li>Operated a variety of hand tools including drills, saws, grinders, and riveters.</li> <li>Inspected welds for accuracy, strength, and adherence to safety standards.</li> <li>Dismantled defective assemblies using hand tools, power tools, hoists, cranes.</li> <li>Utilized thermal cutting tools including oxy-acetylene torches to cut metal components prior to welding repairs.</li> </ul> at Polaris