Sreekanth Madugula

About Sreekanth Madugula

Digitalization of Quality systems, CSV with Risk based approaches. Handling of QMS elements like incidents, deviations and CAPA.Monitoring and closing tickets within timelines. Expertise in regulatory compliance.

Experience

1. Deputy Manager

   Biocon

   Aug 2021 — Present · Hyderabad, IN

   IT Responsibilities1. Infrastructure Management: Ensure the stability, security, and performance of laboratory IT infrastructure, including hardware, software, and networks.2. System Administration: Administer laboratory computer systems, including user account management, software installation, and troubleshooting.3. Data Management: Oversee the management of laboratory data, including data backup, archiving, and retrieval.4. IT Compliance: Ensure laboratory IT systems comply with relevant regulations, such as HIPAA, GLP, and GMP.CSV Responsibilities1. Computer System Validation: Plan, execute, and document CSV activities to ensure laboratory computer systems meet user requirements and regulatory expectations.2. Risk Assessment: Conduct risk assessments to identify potential hazards and mitigations for laboratory computer systems.3. Validation Protocols: Develop and execute validation protocols to ensure laboratory computer systems are validated and compliant with regulatory requirements.4. Audit and Compliance: Ensure laboratory computer systems are audited and compliant with regulatory requirements, such as FDA 21 CFR Part 11 and EU Annex 11.General Responsibilities1. Collaboration: Collaborate with laboratory staff, IT personnel, and external partners to ensure effective IT and CSV operations.2. Documentation: Maintain accurate and up-to-date documentation of laboratory IT and CSV activities, including validation records and audit trails.3. Training: Provide training and support to laboratory staff on IT and CSV procedures and best practices.4. Continuous Improvement: Continuously monitor and improve laboratory IT and CSV operations to ensure they remain effective, efficient, and compliant with regulatory requirements.

Education

• TARA degree college sangareddy

  Bachelor of Science (BSc)

  2003 — 2006

• Osmania University

  MSc

  2006 — 2008

Skills

• Problem Solving
• Employee Relations
• Quality Control Analysis Roles
• Validation
• Microsoft Excel
• Ir
• Recruiting
• Negotiation
• Regulatory Affairs
• Hplc
• Glp
• Customer Relations
• Pharmaceutical Industry
• Sop
• Fda
• Laboratory
• Excel
• Pharmaceutics
• Gmp
• Microsoft Office