Shailesh R

I aspire to join a reputable organization where I can leverage my expertise in Technical Support and Computer Science to make a meaningful contribution. I am highly motivated to take on challenging tasks and work collaboratively to achieve the organization's objectives.

With over 13 years of experience in Pharma-IT and Technical Support, I specialize in meeting GLP and GMP requirements. My expertise lies in managing scientific applications and GxP computer systems, ensuring full compliance with regulatory guidelines, including 21 CFR Part 11.

I am dedicated to applying my skills and experience to drive operational excellence and support the organization's success.

• System Architecture and ImplementationArchitecting, designing, implementing, and supporting analytical applications and their solutions.
  Providing technical support for the installation, configuration, and administration of various enterprise and standalone analytical applications.
• Validation and CompliancePerforming, reviewing, and supporting Computer System Validation (CSV) activities for analytical software.
  Conducting periodic validation and ensuring compliance with regulatory requirements.
  Developing and implementing IT Standard Operating Procedures (SOPs).
• Incident and Quality ManagementInvestigating laboratory incidents (LIR) and preparing detailed reports.
  Managing Quality Assurance Management System (QAMS) activities.
  Reviewing and approving Corrective and Preventive Actions (CAPA) and ensuring timely execution of changes.
• IT Leadership and TrainingLeading the IT department and addressing regulatory and customer audit queries.
  Conducting IT department inductions and providing SOP training.
  Managing the development of role/activity-specific curricula.
• Disaster Recovery and Risk ManagementPossessing expertise in disaster data recovery planning and execution.
  Preparing user requirements and conducting risk assessments for system validation.
• Empower CDS and Stakeholder ManagementManaging Empower CDS system maintenance, upgrades, and application lifecycle.
  Communicating updates on new releases and providing project management support.
  Ensuring professional, timely, and quality-compliant solutions for stakeholders.
• Continuous Improvement and InnovationIdentifying areas for improvement and implementing innovative solutions.
  Adhering to escalation protocols and troubleshooting complex issues.
• Change and CAPA ManagementInitiating CAPA projects, preparing CAPA plans, and providing training for affected personnel.
  Reviewing and approving change actions while evaluating the need for further investigation.
• Budget and Resource ManagementManaging the budget for Chromatography Data Systems (CDS).
  

Specializing in Chromatography Data Systems (Empower CDS), Computer System Validation (CSV), NuGenesis SDMS, and technical support within GLP and GMP environments, I bring expertise in managing scientific applications and GxP environments while ensuring compliance with regulatory guidelines such as 21 CFR Part 11.

My responsibilities include:

• Planning, implementing, and administering systems.
• Ensuring data security and compliance.
• Troubleshooting instrument connectivity and Empower CDS configuration.
• Installation and qualification of Waters HPLC, UPLC, and Empower software.
• Providing technical support for issues such as instrument connectivity, LAC/E installation, and data processing for Waters and Agilent (LC, GC) instruments configured with Empower software.

Additionally, I manage application maintenance, upgrades, validation activities, and stakeholder engagement across multiple global sites, ensuring the seamless operation of critical systems.

• Father's Name: Ramachandra
• Date of Birth: 10/28/88
• Nationality: Indian
• Marital Status: Married