Participate in the development, implementation and maintenance of procedures and templates to enhance the governance and compliance state of LIS systems to a consistent standard.
Participate in the development, implementation and maintenance of templates and business management tools for the evaluation of the data integrity state of Partner including the assembling of tools for resolution of identified gaps.
Develop and deliver trainings on the approach, templates and business management tools for evaluation data integrity state of Partner.
Strategize and schedule trainings for all GPLM users across all sites.
Provide metrics and status of the inspection readiness state for LIS including but not limited to closure of quality records, on-time training, etc. Develop and promote the enhancement of related processes for maintaining a ready state.
Identify and escalate compliance risks and prescribe potential solutions to appropriate levels of management.
Establish excellent working relationships with internal operations as well as regulatory/compliance/quality groups.
Provide awareness to assigned departments and management when specific compliance issues arise.
Assists in evaluation and implementation of standard operating procedures and systems needed to comply with compliance and data integrity requirements. Perform Data Integrity/Compliance assessments of CxO partners (on-site or teleconference).
Performing Risk assessments, defect analysis, authoring validation plan, summary, requirement traceability matrix (RTM), functional requirements, report specification as per 21 CFR Part 11.
Design data process maps for GxP systems and assess them to ensure necessary controls are in place.
Experience with 21 CFR Part 11/ Annex 11 – in the context of Manufacturing and Supply Chain electronic systems
Must have execution/operations experience deploying and supporting Validated systems
Solid Understanding of GMP procedures to follow in deploying electronic systems or system enhancements. Must be familiar with the IQ/OQ/PQ aspects of managing validated systems
Must be comfortable developing methods and deploying data integrity controls in end-to-end Supply Chain processes, across electronic systems
Involvement with system audit trail review and periodic review is desirable
