Quality Systems Specialist

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POSITION SUMMARY:
This position is responsible for carrying out tasks and projects related to document control for Janssen Sciences Ireland (JSI) UC and Janssen Pharmaceutical Sciences (JPS) UC as the need arises by Good Manufacturing Practice (GMP).

These activities include administration owner of the Electronic Document Management System (EDMS), preparation/submission of GMP documentation into and retrieval from archive, and the management of controlled documents through the review, approval, circulation and revision processes.

GENERAL SCOPE OF RESPONSIBILITIES:

- Provides support and direction to all departments (QA, QC, Operations, Maintenance, etc.) With respect to Quality Systems to ensure business, quality and compliance goals are met.

Partners with other departments to ensure that Documentation programs and Records Management policies are completed in a compliant and efficient manner.

- Supports the development and management of GMP compliance systems through the following activities.

- Completion of tasks related to management Document Control and Records management in respect GMP regulatory requirements.

- Provide mentorship on the site document control and records management procedures and policies.

- Reviews received documents for conformance to site systems specifically EDMS and GDP requirements.

- Liaises with document owners in respect of approval schedules and implementation of new or revised documents.

- Provides feedback from document review to the document owners.

- Administrative tasks within the EDMS system including but not limited to:
à Granting User access to the system and assigns privileges
à Coordinates routing of SOPs and other GMP regulated documents.
à Supervises documents during the review and approval processes and advises relevant personnel accordingly.
à Participates in upgrade and improvement activities of the system as appropriate.
à Generates reports and metrics from the system.
à Develops and applies systems and procedures related to the EDMS system.

- Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.

- Coordinates the Records Management Policy for the site and carries out tasks related to the storage and archiving of GMP documents related to JSI/JPS, in line with J&J records retention standards and guidelines.
à Prepares and catalogues documents for archival.
à Coordinates with internal and external ...