Overall Job Purpose:

This position is responsible for supporting the site, department(s) and/or Project(s) to which they are assigned with respect to computer system development, validation, and maintenance. This role is responsible for procedural interpretation and training. The QA ensures inspection readiness within those areas supported and participates in regulatory agency inspections, as needed.

Job Responsibilities:

Provide direct quality oversight of computerized systems.
Review and approve documents supporting computerized systems and validation including, but not limited to, procedures, deviations, periodic reviews and change proposals.
Provide quality guidance and recommendations with regard to computer system issues.
Conduct gap assessments of global requirements and ensure implementation of the governing standards.
Review and approval of computer system (automation) related work orders.
Provide coaching, feedback and mentoring to QA and site personnel as it relates to computerized systems and validation.
Understand data integrity requirements and practice during validation and routine operation.
Participate in site data integrity strategy and assessment activities.
Lead/Support investigation and evaluation of computer system related incidents and/or deviations
Participate in the review/revision of global quality standards related to computerized systems, if needed.
Ensure areas are inspection ready and compliant to established systems/procedures.
Participate in and/or support regulatory inspections and audits.
Assist others in the interpretation of regulatory and corporate requirements supporting computerized systems.
Establish and maintain site quality system for computer system to meet regulations including Japanese GMP, Computer system guideline, GQSs and LQSs.
Attend Process Team(s) (e.g., Manufacturing, Utilities, QC, etc.) Flow Team(s) (i.e., FUME, QC, Engineering) Lead Team(s) (i.e., Data Management, Continuous Improvement, IDS, QA, etc.), as required.