KARTHEEK NAGINENI
INDORE
Summary
Accomplished Assistant Manager at Mylan Laboratories (Viatris Company), adept in change controls and fostering team collaboration. Excelled in risk assessments and system validations, enhancing regulatory compliance and operational efficiency. Proven track record in mentoring staff and driving strategic business improvements, demonstrating exceptional project management and interpersonal skills.
Overview
10
10
years of professional experience
Work History
Assistant Manager
Mylan Laboratories (Viatris Company)
Indore
02.2015 - Current
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Initiated change controls in Trackwise application related to Engineering modifications and Equipment installations.
- Performed Risk assessments related to modifications and equipment installations as per regulatory requirements.
- Performing Engineering systems risk assessments and evaluating periodically as per FDA requirements.
- Performed contamination studies with respect to HVAC and Water systems and shutdown studies as per various regulatory studies.
- Performing and reviewing the equipment qualifications as per ISO clean room classifications.
- Ensuring compliance with respect to periodic activities like Preventive Maintenance, Calibrations and building management in regulatory aspects and developing the procedures accordingly.
- Identifying the contractor/ service providers for various technical operations and evaluating, auditing and making agreements.
- Performing Computer System Validations (CSV), PLC validations and area validations with respect to regulatory compliance.
- Preparation and reviewing of SOPs for daily operations and revision as per requirement within the compliance.
- Involved in daily routine breakdown activities related to instrumentation activities.
- Coordinate with OEM persons with respect to equipment/ systems compliance with respect to regulatory standards.
- Reviewing the drawings, periodic schedules and logbooks in view of compliance.
- Developed strong working relationships with staff, fostering a positive work environment.
- Managed inventory levels to minimize stockouts while reducing overhead costs.
- Mentored junior staff members in their professional development by offering guidance/support in their assigned roles.
- Collaborated with the management team to develop strategic plans for business growth and improvement.
- Promoted teamwork within the workplace by encouraging collaboration among staff members on various projectstasks.
- Ensured compliance with all safety regulations by conducting regular inspections of equipment/operations at site.
Education
Bachelor Of Technology - Electrical, Electronics And Communications Engineering
Jawaharlal Nehru Technological University (JNTU)
Kakinada (AP).03.2012
Diploma - Electrical, Electronics And Communications Engineering
State Board of Technical Education And Training
Chirala04.2009
Skills
Workload Management
Change Controls
CAPA
Risk assessment
System Risk Management
Computer System Validations
PLC validations
Equipment Qualification
Water system compliance
SOP preparations and review
Technical Agreement
Instrumentation breakdowns
PM, Calibration activities
Orientation and training
Project management abilities
Cost Reduction
Cost Control
Project Management
Contract Management
Preventive Maintenance
Projects
1. Installation and validated the Digital Ethernet based IP wall clocks.
2. Installation of networking printer for standalone equipment for centralised printouts and Data backups.
3. Installation and validation of Environmental Monitoring system in process areas at site.
4. Design and Qualified 0.5 billion capacity plant including HVAC systems.
5. Involved in 0.5 billion capacity of OEB4 manufacturing block design and Qualifications.
6. Implemented various Automation Activities at site.
Languages
English
Bilingual or Proficient (C2)
Hindi
Upper intermediate (B2)
Telugu
Bilingual or Proficient (C2)
Marathi
Intermediate (B1)
Timeline
Assistant Manager
Mylan Laboratories (Viatris Company)
02.2015 - Current
Bachelor Of Technology - Electrical, Electronics And Communications Engineering
Jawaharlal Nehru Technological University (JNTU)
Diploma - Electrical, Electronics And Communications Engineering
State Board of Technical Education And Training