We are seeking a professional to assist operational teams in safeguarding the trustworthiness of records generated by their computerized platforms. The position works hand-in-hand with technical, quality assurance, and IT functions to strengthen sound record-keeping habits, lend a hand throughout audits and regulatory visits, and confirm that platforms are operated in line with requirements.
Key activities
* Serving as the go-to expert for the organization's computerized data-handling platforms
* Confirming that platform usage adheres to accepted record-trustworthiness standards
* Conducting record-integrity examinations and event-log inspections
* Reviewing account privileges, authorization tiers, and platform setup choices
* Backing qualification efforts alongside the quality and IT groups
* Participating in non-conformances, investigations, root-cause analysis, and remediation/preventive measures
* Harmonizing record-trustworthiness habits across the various teams
* Authoring and upkeeping standard procedures and reference materials
* Keeping the organization prepared for audits and regulatory visits at all times
* Carrying out paperwork checks and pre-visit verifications
Essential background
* Demonstrated track record within a controlled (GxP) setting
* Firm grasp of record-trustworthiness fundamentals (ALCOA+)
* Event-log examination
* Stewardship of the record's full lifespan
* Readiness for regulatory visits
* Hands-on background with remediation/preventive measures and non-conformances