Primary Responsibilities include:
1) Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by reviewing the validation packages of IT applications in a regulated industry.
2) Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams across Healthcare in appropriate verification and validation testing requirements.
3) Support Quality & Regulatory Validation Operations group in following the established process and procedures for Validation in Healthcare business.
4) Provide guidance/feedback to IT applications group in Validation compliance as per the applicable regulatory requirements and Company Healthcare policies and procedures.
5) Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.
6) Create and revise Validation Standard Operating Procedures (SOPs) and other documentation to support the Quality System in regards to validation compliance.
7) Recommend and lead corrective and preventive actions (CAPAs) to improve the validation practices.
8) Provide practical solutions to a wide range of difficult challenges in IT validation independently
9) Work independently to determine and develop solutions that are innovative, thorough, and practical
10) Support the internal/external audits and regulatory inspections form validation perspective.
Bachelors degree (BSEE) in engineering and IT related fields; but any advanced degrees are preferable in Quality, Regulatory or Software Engineering.
7+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.
5+ years of experience with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC, IEEE and industry best practices).
Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.