Vamseekrishna Maddi
Visakhapatnam
Summary
Detail-oriented Assistant Manager offers progressive record of accomplishment in Quality and Audit management, Qualification of equipment and Computer System validation. Establishes clear guidelines and enforces consistent policies to keep staff satisfied and on-target to achieve important objectives. Excellent relationship-building, multitasking and decision- making skills. Proven track record in regulated and complex markets including USA, Japan, Europe, Canada, etc. Enthusiastic and keen in exploring the field of Regulatory.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Assistant Manager
Laurus Labs
Visakhapatnam
06.2022 - Current
- Accomplished in installation of Blister Packing Line and Bottle Packing Line including Track and Trace systems, from URS to equipment release for commercial use
- Assisted in the development of operational strategies to ensure efficient and Productive operation
- Ensured compliance with safety regulations and company policies
- Expertise in initiation and closing of change control; preparation and review of Batch Packing Records, SOPs, Protocols, Qualification Documents, Deviations, Market Complaints investigation reports, Audit response report
- Experienced as an internal auditor in the organization
Junior Manager
Eisai Pharmaceuticals India Pvt. Ltd
Visakhapatnam
06.2017 - 06.2022
- Managed new projects like the Jekson Track and Trace system and label generation from Track & Trace with SAP integration
- Initiated and closed change controls for equipment, software, and process changes
- Prepared Risk Management, URS, Protocols, Validation documents, and Traceability matrix
- Conducted deviation investigations and proposed effective corrective and preventive actions
- Conducted training sessions and ensured timely completion of SOP training
- Utilized SAP transactions for efficient operations
Executive
Orchid Healthcare
Chennai
07.2014 - 06.2017
- Worked as a supervisor in Manufacturing and Packaging
Trainee
Fourrts India Laboratory Pvt. Ltd
Chennai
05.2013 - 06.2014
- Worked as a trainee in Granulation and Compression areas
Education
M. Pharmacy - Pharmaceutical Sciences
Andhra University
Visakhapatnam, India11.2012
B. Pharmacy - Pharmacy
Avanthi College of Pharmacy
Visakhapatnam, India04.2010
Skills
- Quality management system
- Auditing Management
- Risk Management
- GAMP 5
- EU Annex11
- 21 CFR Part 11
- 210
- 211
- Team leading skills
- Trackwise
- Ample logic
- Traceability matrix
- Strong verbal and written skills
Certification
- Certificate of Completion in Project Management Foundation course.
- Certificate of completion in Excel Essential Training (Microsoft 365) (2018)
Projects
- Track & Trace systems Ample Logic LMS and DMS Trackwise updation SAP integration in Jekson Track & Trace Blister and Bottle Packing line
Awardsandhonours
- Got 2 promotions in less than 4 years for achieving better productivity and completing projects well before the deadline during my tenure with Eisai Pharmaceuticals India Pvt. Ltd. In 2019 & 2021.
Timeline
Assistant Manager
Laurus Labs
06.2022 - Current
Junior Manager
Eisai Pharmaceuticals India Pvt. Ltd
06.2017 - 06.2022
Executive
Orchid Healthcare
07.2014 - 06.2017
Trainee
Fourrts India Laboratory Pvt. Ltd
05.2013 - 06.2014
- Certificate of Completion in Project Management Foundation course.
- Certificate of completion in Excel Essential Training (Microsoft 365) (2018)
M. Pharmacy - Pharmaceutical Sciences
Andhra University
B. Pharmacy - Pharmacy
Avanthi College of Pharmacy
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