KEVIN JOSE

• Manufacturing of pharmaceutical products in state-of-the-art production facility adhering to strict quality measures and ‘Right First Time' practices.
• Experience in the manufacture /handling of controlled substances.
• Follow all applicable SOPs, WIs, GMPs and company
  policies/regulations.
• Assisted in revising and modifying SOP's and Batch production records BPR's to make work more efficient & less laborious in order to achieve optimum production targets in a cGMP compliant manner.
• Executed applicable SAP (including PM notifications) in a timely
  manner.
• Working with LabWare LIMS and making appropriate labels and performing Electronic Scale calibrations accurately and in a timely manner. Responsible for the Sanitation, Set-up, Start-up & Safe operation of Tablet presses (Bosch X500, Fette FE35, Manesty NovaPress, Korsch PH300 and PH800).
• Complete all documentations accurately as per GDP requirements.
• Provide assistance during FDA, Health Canada and other customer
  audits to ensure compliance to cGMP regulations and standards.
• Assist in CAPA activities to address deviations and ensure continuous process improvement.
• Performed troubleshooting activities to ensure production efficiency and minimize process deviations.
• Assist Validation Group with new product launches to achieve optimum performance and establish parameters adhering to GMP guidelines.
• Help in APR to find root cause to deviations by using RCA.
• Familiarity with Equipment and Process validations (stages and procedures).
• Assist in department LEAN, Kaizen, Transcend and 5S
  implementation activities to enhance processes, boost productivity & increase profitability by minimizing wastage of resources effectively.
• Knowledge in using integrity tester, tachometers and tube sealing methodologies.
• Provide Technical training and conduct Technical Assessment of new employees.

• Strengthened merchandising and promotional
strategies to drive customer engagement and boost
sales.
• Helped with planning schedules and delegating
assignments to meet coverage and service demands.
• Monitored cash intake and deposit records,
increasing accuracy, and reducing discrepancies.
• Monitored security and handled incidents calmly.
• Verified inventory counts remained within monthly
tolerance levels and compiled financial data in
compliance with budget.
• Reconciled daily sales transactions to balance and
log day-to-day revenue.

• Experience in Manufacturing facility (GMP) which
included analysis of Engineering drawing and
testing.
• Applied Mechanical Engineering concepts to
improve the design of the product.
• Strong knowledge in Geometrical dimensioning and
tolerancing (GD&T).
• Used AutoCad to generate product drawing and
transferred for further manufacturing process.
• Used Solidworks software for assembling different
parts and thermal testing was done using Ansys.
• Expertise in using Quality tools such as Continuous
improvement, Lean Six-Sigma, Value stream
mapping, Statistical Process control and Quality
Audit.
• Periodic maintenance was conducted to ensure
safety of manufacturing process.