Johnson & Johnson Careers
Specialist, PV CAPA Management
Requisition ID: 1905744216W
The Specialist, CAPA Management will be responsible for providing support in the oversight and execution of the E2E CAPA (Corrective and Preventive Actions) Management process for Pharmacovigilance (PV) CAPA.
The Specialist, CAPA Management will be responsible for the management of the department mailboxes and for notifying E2E PV CAPA record owners to ensure they adhere to the process timelines. The Specialist, CAPA Management will initiate TrackWise records as needed and provide CAPA system guidance to ensure the system field requirements are met to enable effective reporting and governance. The Specialist will be responsible for the CAPA Management system user administration.
The Specialist will be responsible to review and approve documented evidence provided by CAPA owners to satisfactorily close corrective action plan commitments from non-conformance investigations or audit observations. This role is responsible to work with CAPA record owners to communicate any deficiencies in documentation to allow for resolution in a timely manner in accordance with prescribed due dates. The Specialist will be accountable to quality check documented investigations and CAPAs against SOP requirements for the CAPA process and to correct or escalate issues as needed for resolution.
Under the leadership of the Associate Director, PV CAPA Management Center of Excellence (CoE) the Specialist will utilize appropriate metrics and reports to allow for the proper oversight of the CAPA process and its effectiveness in timely resolution of CAPA issues.
- Support CAPA Managers/Directors with the CAPA Management process lifecycle:
- Support investigation owners for process deviations and audit findings and monitor progress of timelines for investigations and root cause analysis (RCA) toward achievement of final approvable, appropriate corrective/preventative action plans.
- Utilize reports and tools to prioritize the lifecycle management of records in Trackwise CAPA Management IT platform according to established business objectives and due dates.
- Review and approve documentation and evidence provided to satisfactorily close corrective action plan commitments from non-conformance investigations or audit observations.
- Perform User Administration and Support duties including user access requests, user training, maintaining current user lists and other duties as necessary. Provide Trackwise technical expertise to users for all phases of CAPA Management process including reports and metrics. Facilitate oversight through use of CAPA Management related metrics and dashboards. Generate reports using Trackwise system tools.
- Perform other duties in support of PV CAPA Center of Excellence, as necessary.
- Bachelor’s degree in technical, science, or business field (or equivalent).
- Experience working in pharmaceutical or other related regulated industry.
- Demonstrated quality systems experience and good documentation practices. Preferred experience in non-conformance investigation and CAPA as an investigator, contributor and/or reviewer/approver.
- Must be able to fluently read, write, and speak English.
- Excellent communication and writing skills demonstrated by the ability to write clear, compliant executive summaries, as well as compile and present information to colleagues.
- Knowledge of pharmacovigilance regulatory requirements and experience with safety processing, clinical study safety reporting, pharmacovigilance and medical information.
- SOP development experience in pharmaceutical or other related regulated industry.
- Experience supporting audits and/or inspections.
- Project management experience.
- Global/regional working experience (working remotely with others on business deliverables, via telephone, email and other means).
Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ