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Project Management Vendor

Location:
Wake Forest, NC, 27587
Salary:
80000
Posted:
May 16, 2024

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Resume:

*+ years of experience working as a professional in diversified Manufacturing industries. I possess an in-depth understanding and am well-versed in federal and ISO regulations in the Pharmaceutical, and Manufacturing industries regarding the complete process of supplier management, Vendor Analysis, equipment installation, assembly, and validation. I excel in project management, coordinating cross-functional teams to ensure goals and timelines are achieved. I am eager to venture into my next opportunity where I can utilize and expand upon my current skills. I am interested in continuing my professional path expanding my knowledge and developing further along with the organization.

Core Competencies and Advanced Proficiencies:

Technical:

Good Manufacturing Practices (GMP) Code of Federal Regulations (CFR) 21 Internal Auditing Good Documentation Practices (GDP) External Audit Support Six Sigma Methodologies such as Five Whys, Fishbone, FMEA, Kanban, Muda Assessment Authoring Standard Operating Procedures (SOP) Change Control Management Corrective Action Preventive Action (CAPA) Deviations Investigations Root Cause Analysis Qualification and Requalification of Vendors & Suppliers International Standard Organization Compliance Vendor Management Maintenance Training Trouble Shooting Temperature Mapping Summary Reports Technical Transfer & Regulatory Support

Systems:

Trackwise Digital Oracle Microsoft Office – Word, Excel, PowerPoint, Visio, Project, and Pivot Master Control SAP

Utility Systems and Equipment:

Reactor Kettles, Receivers, Centrifuges, Dryer, Mill, Micronization, TCMs Fume Hoods, Laminar Air Flow Booths, and Dispensing Rooms

Temperature Mapping - Refrigerators, Freezers, Walk-in & Reach-in Coolers, Stability Chambers

Curia Global Inc - Quality Assurance Specialist 2022 – 2024

Material Disposition review and update status of Factory supplies, Raw materials, and Intermediates and Final Products Supplier Qualification activities Risk assessment and periodic evaluation of suppliers Supplier document review Communication with suppliers and distributors on a day-to-day basis Prepare and review protocols for critical materials Customer communication and approval for Critical raw materials, intermediates, and Final Products Supplier Quality agreements Perform Supplier Audits Support External and Regulatory Audits Support daily plant meetings for release and disposition of materials Prepare and update Approved supplier lists and

product-wise supplier lists Qualify and Re-qualify or disqualify suppliers through Change controls Management Conduct Gemba Walks to review product storage and shipments in the warehouse Review and approve Factory Trial lots for use in daily production Participate in Daily Review & Release (R&R) Meeting to communicate status with cross-functional teams.

Leadership Responsibilities:

Lead for Supplier Qualification and vendor management.

Led GEMBA Walk, and Internal Auditing and Shipment verifications for a variety of Products.

Review Supplier & validation documents and Product Release activities on a routine basis.

Data Sycle LLC – Contractor – Quality Validation Engineer 2021-2022

Reviewed commissioning activities, and Documents for equipment, checking pre-installation and post-installation criteria, and hand-over of equipment for production Performed internal GMP audits in production and warehouse areas to ensure process and product compliance Executed empty and loaded chamber temperature mapping using data loggers, and chart recorders Reviewed SOPs for production equipment, lab equipment, and utilities Partnered with cross-functional teams to review the accuracy of the status of shipments Vendor management including obtaining quotations from different vendors, issued purchase orders for procuring parts, and maintained inventory Reviewed production batch records and cleaning batch records Performed and supported all audit activities including follow-ups and closures activities

Eruvaka Technologies Pvt Ltd – India 2018– 2019

Planning and Scheduling for Production, Operations, and Shipping of Pond Mother, Pond Guard & Shrimp talk devices Material handling and inventory management Led team of technicians and was responsible for review of equipment and fixtures installation, commissioning, and handover to production for regular assembly operations Identification of multiple suppliers, price and lead time negotiation Quality Inspection of shipping & received materials QA & QC for products under assembly/modification, finish and rejected using Quality First and Quality by Design Principles to reduce all types of wastes and increase process efficiency and productivity

Nagarjuna Fertilizers & Chemicals Ltd – HR Generalist – India 2015-2017

Talent Acquisition Specialist based at the Corporate Office Assist in Employee Induction, Workforce planning, and Succession Planning based on Organization goals Recommend the Design of organization structure for functions and departments Identifying training needs through competency mapping of skills by analysis of existing competencies Responsible for Designing and Evaluation of Goal setting and productivity metrics to measure efficiency and effectiveness.

Cummins India Pvt Ltd – Asst Manager – India 2012-2014

Responsible for Installation & Commissioning of Material handling systems at KV engine stores Working with vendors and stakeholders for the Design Approval Process, and developing Cost & Effect analysis for storage rack suppliers Facilitated an effective material handling system with sprinklers and 70% perforations assuring Quality, safety, long-term reliability, and strength for the KV rack system Recommended the Engine Assembly through Six Sigma & Value Stream Mapping resulted in Reduction of cycle time for QSK -23 at Mega site – Cummins, Phaltan Researched and Provided analysis on work instructions, time study, work-study at each station of QSK- 23 engine Series for improvement of assembly process Executed Value Stream Mapping for QSK -23 Engine Assembly, which reduced the Total Lead time from Engine Assembly to dispatch by 50% Prepared charter for Six Sigma by identifying the bottlenecks, and trained in DMAIC for project execution at the plant

Master of Engineering in Human Resource Management IPE-Hyderabad 2016

Bachelor of Technology in Industrial & Production Engineering – ANU- Guntur 2012

Certified Process Technician (CPT)

Six Sigma Trained Belt Certification (Cummins Inc.)

Experienced Professional in Scope of Quality, Vendor Management, and Project Management

Professional Experience

Education and Certifications



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