QA Leader, Life Science Service Enterprise

Role Summary/Purpose:
As the QA Leader you are responsible for QA support by driving compliance activities around the Global Service & Enterprise Solutions business which includes Flex Factory & KUBio. This role is also responsible for completing and maintaining oversight of both supplier and customer related activities including but not limited to document control, compliance training, customer interactions, complaints and CAPA management. Do you want to work in a global team? Join GE now!

Essential Responsibilities:

? Acts as QA lead support to regional Flex Factory (FF)/KUBio projects supporting milestone reviews.
? Provides QA Support to Global Flex Factory/KUBio projects as requested.
? Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
? Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.
? Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency for the Enterprise solution business.
? Ensures process compliance through the development of comprehensive procedures, workinstructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
? Supports continuous product and process improvement through detailed failure analysis for nonconformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
? Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
? Ensures readiness of facilities, systems, and operating mechanisms in compliance with GEHC and Life Sciences (LS) requirements.
? Coordinate validation protocols and reports from draft to approval
? Support on-site document control, including but not limited to, documents from SAT, Automation, IQ, OQ etc.
? Supports Service QA in hosting Customer audits related to Flex Factory/KUBio

Qualifications/Requirements:

? Bachelor?s degree or equivalent knowledge and experience.
? Proven experience of Quality Assurance/Regulatory Assurance in a regulated industry or a Masters degree or equivalent knowledge and experience.
? Ability to communicate effectively in English (both written and oral).
? Demonstrated validation experience in pharmaceutical or medical device industry.
? Familiarity with HVAC system, WFI, PW and automation for environmental monitoring requirements.
? Demonstrated understanding or aptitude to understand Medical Device QMS & Pharmaceutical.
? GMP regulatory requirements including but not limited to FDA CFR 21 820, 210/11, ISO9001 & ISO13485.
? Ability to travel and work at customer site based on needs from different project phases
? Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.