Arif Abbas Email & Phone Number

Marlborough, Ma, Us

Lead a team of engineers in conducting independent review of equipment software qualification documentation for medical device manufacturing systems, Labs, facilities and local IT system.•Partner with Validation, software Engineering and labs to drive efficient and effective equipment software qualification solutions.•Manage resources and lead, direct, organize and control department AOP.Mentor, coach and develop staff to increase their effectiveness as well as employee engagement by creating a collaborative, learning environment.

Tokyo, Jp

Providing leadership as the management representative for Validation at a biologics manufacturing facility.•Managing the site validation program and activities for manufacturing equipment, utilities and facilities qualification, computerized systems validation, shipping validation, cleaning validation, and process validation•Influencing and directing employees and contractors at all levels to ensure all necessary Commissioning and Qualification activities are completed on time, and according to applicable procedures.•Responsible for developing, managing and implementing validation program to ensure products meet with appropriate regulatory agency requirements, internal company standards and current industry practices.•Primary liaison for site validation in Regulatory inspections.

Illinois, Us

• Established a risk-based Validation program that delivered compliant systems while reducing project cost and minimizing impact on schedule. • Integrated site validation program with a center lead approach that harmonized activities across groups.• Supervised the validation of JD Edwards, Laboratory systems, Network Infrastructure and metrology systems. Managed change control and CAPA for computerized systems with minimum downtime.• Established software supplier quality program that reduced project cost while increasing quality results. • Successfully managed resources, billing and invoicing process, and tracked project deliverable

Minnetonka, Minnesota, Us

Leading offshore/onshore test resources in delivering high quality advanced visualization tools, clinical applications, and data management systems.•Produced high-quality results by creating, implementing and maintaining effective QA processes, enhancing roles within system life cycle and promoting risk-based test strategies.•Successfully lead simultaneous projects through all stages of SDLC while providing independent judgment to set clear milestones, produces project deliverables, and provide team leadership.•Worked directly with Development, Marketing, Product Analysts, User-centered-design, and Customer Support in increasing and maintaining product quality.•Created and maintained dashboards to monitor project status, reinforce goals, and help promote transparency among project teams.•Provide result oriented mentorship and delegated tasks leading in growth of individual expertise.•Updated Validation and verification processes to align with IEC 62304.•Lead the Validation team in securing 510(k) clearance from FDA for CT TAVR (transcatheter aortic valve replacement) planning application.

Eden Prairie, Minnesota, Us

QA lead of enterprise-wide data achieving and management solutions• Manage 10+ QA onshore and offshore resources. • Responsible for allocating and managing work assignments, resource allocation, progress tracking, defect management and documentation review.• Generate and report test metrics to project team.• Develop test plans, project estimates, build schedule and release management activities.• Deploy, manage and maintain test environments for functional, performance and User acceptance testing.• Define testing strategy for unit, integration, smoke, functional, System, End-to-end, performance and beta testing.• Participate in requirements gathering, functional design reviews and production deployment planning.

2500 Valby, Dk

Managed computer validation activities including supervision of consultants, managing projects, change control implementation, QA and validation assessments, and CAPA and deviation management.Department Lead in testing LIMS, SAP, EDMS, Plateau LMS, TrackWise, QC equipment, Network Infrastructure, and other ERP systems and maintaining their compliance with FDA regulations

Consulting for life sciences industry with a focus on validating systems used in the manufacturing of over-the-counter drugs products. Clients include:CIMA Labs

Rochester, Minnesota, Us

Software QA Lead for IBM AIX platform based Lab Information System (LIS) used by 40 specialty laboratories, performing more than 13 million Pathology tests a year and a major revenue source for Mayo Clinic.• Test Lead for successful maintenances releases of LIS, with minimum downtime while successfully delivering user requested changes and maintaining business operations.• Carried out integration testing between LIS, patient registration and discharge system, physician ordering and review system, SAP CRM system, finance and billing system, and peripheral devices.• Testing of Waters NuGenesis SDMS, ERP systems, web based system and integrated hardware devices.• Successfully tested complex Health IT systems in Agile development and waterfall model.

Downingtown, Pennsylvania, Us

Design and validation of automation process control, BAS and Utilities for Pharmaceutical manufacturing. Clients include:Merck, Johnson & Johnson• Validation of protein purification processing skids operated on DeltaV automation platform.• Installation and operational qualification of device/equipment control (control modules and equipment modules), operator interface, and batch control (phases and recipes).• Planned the implementation and validated DeltaV controlled BAS/HVAC monitoring system.• Developed and executed IQ/OQ protocols for eight manufacturing skids, automation systems, utilities and BAS/HVAC systems for the Human Papillomavirus (HPV) vaccine manufacturing facility.

Durham, North Carolina, Us

Consulting for ERP system validation and infrastructure qualification with Clients including Wyeth and Pharmacia.• Validation Lead role for a three site deployment of ISOtrain® Training Management System with a focus on client satisfaction, and delivering a quality application compliant with FDA and EU regulations.• Supervised the validation of Maximo® maintenance and management software and Blue Mountain CALMAN calibration manager• Developed strategy for migrating training data from legacy system database to ISOtrain® and supervised the validation process that ensured the integrity of the data migration.• End user testing of EMC Documentum verifying user requirements. Testing included verification of GUI functionality, document workflows and system security.• Performed gap analysis and prepared SOPs Network Infrastructure qualification.

Durham, North Carolina, Us

QA Consultant for new drug development and qualification of process utilities for pharmaceutical clients including Elan, Pfizer and Merck.• Project Lead for R&D and commercial deployment of revolutionary AccudepTM electrostatic deposition technology that allows manufacturing of very accurate solid oral dose pharmaceuticals.• Successfully managed project activities including client communication, staffing, and tracking cost.• Developed requirements for a document management system suitable for a startup company and evaluated PTC Windchill and EMC Documentum functionality against these requirements.• Prepared user requirements, and design specifications for mechanical and software modules.• Lead QA group activities to prepare client for FDA pre-approval inspection and developing a vendor audit program. • Developed training on FDA regulatory requirements and various system life cycles models• Validation of WFI (water for injection) generation and distribution system for a R&D facility.• Team leader in the validation of a refrigeration system for an off-site cold storage facility.• Commissioning and validation of HVAC System controlled by Siemens APOGEE® System.

Durham, North Carolina, Us

Consultant for drug development and manufacturing industry with clients including Bayer Corp.• Analyst team leader that successfully assisted plasma products manufacturing facility achieve its regulatory compliance commitments and pass FDA audits.• Supervised project activities including managing tasks, client communication, coordinating on-site employee team activities, tracking project cost and generating weekly status reports. • Prepared guidelines and performed training to carryout cGMP gap analysis on the qualification status of WFI generation and distribution system, process equipment and filling line stations.• Supervised a team of six engineers in the qualification of process vessels, centrifuges, storage and hold areas, WFI supply and distribution, clean steam and process air.• Prepared specification documents including design specifications, P&IDs and process flow diagram