GXP Systems Validation Lead

GXP Systems Validation Lead

Oregon City, California

12+ Months

Job Description:

Configuration Specialists and Tester Team (Leads) Determines validation approach, identifies deliverables needed or impacted by a project enhancement or change for GXP computerized systems and Infrastructure Responsible for the review of software documentation according to CSV corporateSOP39s, and regulatory guidance Provide estimates and forecast validation activities for a project Author validation plans reports, reviews test plans reports (and other deliverables) to asses and notify that system is ready to go life Determine testing strategy, requirements and acceptance criteria Liaison with business quality informatics quality to ensure compliance with corporate equality policies and standards Coordinate and advise on all validation activities on a global level organizational level for system project Participate actively in validation discussions, provide consultancy for all validation related questions Participate in system implementation and maintenance planning Lead and author system and functional risk assessments Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions Review and collect expected CSV deliverables, records and other evidences according to plans Prioritize activities in line with the project schedules, business needs and compliance requirement Ensure code release to production and maintenance procedures are identified and adhered Confirm initial data loading and or data migration from other systems, are performed according to approved procedures Assess changes to determine potential impact to the validated state of the computerized system Support system maintenance with validated state and permanent audit readiness Lead and author system periodic review according to procedure Observe governance processes, escalates area for improvement Support system audit inspection preparation and execution as CSV subject matter expert Assures strategic essential oversight over validation support within the department and provides support consultancy for the team and within the global organization if necessary.

Implements relevant framework and processes, propose and uses tools Providing training and validation quality knowledge experience exchange support Prepares recommendations for process optimization in his her area of influence.

Provide input and guidance for a computerized system retirement planning Demonstrates proficiency in g Suite Demonstrates basic knowledge of SAP and MES systems and the interfacing thereof Demonstrates ability to explain complex concepts with clarity and simplicity Demonstrates ability to perform detail-oriented work with a high degree of accuracy Demonstrates strong verbal, written, and interpersonal communication skills.

Skills 7 years experience in IT amp Software Validation (CSV, GAMP)

Education: At least a bachelor s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or a closely related field is required for the project