Validation Lead/Manager Resume

SUMMARY

More than 15 years of experience and over 12 years in Pharmaceutical and Biotechnology industries working as a Validation Manager/ Lead for major Pharma companies Otsuka, Abbott, AbbVie and Merck primarily focusing on Computer System Validation, Process Validation, Equipment Validation and Software Quality Assurance.
In - depth knowledge and experience in understanding ofValidationLife Cycle, Software Development Life Cycle (SDLC), Defect Life Cycle,Agile methodologies in Computer SystemsValidation in Abbott Laboratories and Merck assignments.
Ensure Computerized systems are compliant with applicable 21 CFR Part 11, EU Annex 11 regulations.
Experience in FDA regulated environment and research laboratories with good understanding ofGxP:GDP,GCP,GLP, cGMP,GAMP4andGAMP5 standards, SOX regulations and Corrective & Preventive Actions (CAPA).
Guide teh Project team for any queries/questions associated with CSV and/or teh process to be followed in CSV of teh Computerized systems.
Prepare teh Validation documents for teh Projects/Change Requests.
Create/Review/update teh SOP’s based on company guidelines
Experience in developing validation protocols(IQ, OQ, UAT and PQ), Validation Master Plan (VMP) and Validation Summary Report (VSR)
Experience in Risk Characterization, Risk Assessment,Gap Analysis and developingRemediation Plans
Thorough knowledge in developing Corrective and Preventive Action (CAPA) reporting on process deviations
Experience in Test Execution in handling Validation/System Testing which includes Validation Manager, Validation Lead, Business Analysis, Test Execution, support UAT and Automation Testing.
Experience in SOX Regulatory compliance auditing of information technology infrastructure and applications for Abbott. Coordinate testing/auditing of IT financial systems.
Experience on Xybion developed Pristima application (Pre-Clinical) on Study Management, Clinical Signs, Time Bleed Collect, Pharmacy Inventory and formulations, Dosing and many more.
Experience in specialization of maintaining content management CARA application and publishing systems by Generis.
Experience on Abbott Laboratories - StarLIMS product for ERP Integration module.
Experience in Mobile testing and Forefront Identity Management application
Experience in Content management systems Team Center and Veeva PromoMats
Experience in Test Management tools like JIRA, HP Quality Center ALM and many more for software test life cycle management.
Experience in Data Warehouse projects testing using tools Informatica and Cognos Reports, SAP-ERP testing in validation environment
Manage onsite/offshore teams globally.
Certified Scrum Master from Scrum Alliance

TECHNICAL SKILLS

Validations: FDA Regulations - 21 CFR Part 11, Annex 11, cGMP, cGLP, cGCP, cGDP

Programming Languages: C, Java

Databases & Tools: Oracle, SQL Server, MS-Access, Toad, SQL Navigator, Cognos Reports

Other Utilities: HP Quality Center, Selinium, Clear Quest, WinRunner, Test Director

Internet Tools: ASP.NET, VBScript, JavaScript, Web Services, SharePoint 2003/2007

PROFESSIONAL EXPERIENCE

Confidential

Validation Lead/Manager

Responsibilities:

He is ensuring dat teh Computer Systems developed and delivered meets teh defined Process & Compliance standards and adheres to teh CSV,
Software Development Lifecycle guidelines as specified by teh Quality Manual and Standard Operating Procedures.
Provides consultation for developing teh Validation strategy and addressing any deviations from teh processes.
Responsible for supporting internal CSV audits, external agency audits on regulated applications and managing teh training compliance of project team members.
Model N implementation for Contract Management system - 2016 to 2017
Team Center(Siemens) server Migration PLM product - Abbott Nutrition 2016
Implemented teh Customer Care Calendar and Segment Scheduler(PTC) using Mobile apps for FSR(Field Service Representatives) worldwide using Pega software – for Abbott Diagnostics from 2014 to 2015
Successfully managed and implemented Global Trade Management software (Amber Road) Project -2012 to 2013
Multiple upgrades of Pristima (Xybion) – 2010 to 2012

We provide IT Staff Augmentation Services!

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship