QA Documentation Specialist

Summary

A QA Documentation Specialist is required for a biopharmaceutical company in Cork. The successful candidate will be responsible for maintaining and continuous improvement of site quality systems, providing quality oversight of the facility with a focus on document management quality system.

Responsibilities

• Process site-controlled documents on the site Document Control System.
• Approve document change controls and establish document effective dates.
• Complete work according to established priorities and policies to assure product documentation is delivered on schedule.
• Support and train other staff members on the implementation of global improvements related to the Document Control System.
• Train and support other staff members on the use of the Document Control System.
• Maintain the Sites Document Store and elevate any potential issues.
• Control and issue controlled document numbers as required.
  Support Inspection Readiness for the site and the site in preparation for upcoming inspections.
• Examine the Quality Metrics related to the Document Control System.
• Participate and support Continuous Improvement for the Quality Team.
• Other duties may be assigned as requested.

Qualifications & Experience

• Similar experience in a regulated environment.
• Experience with QMS and EDMS systems is desirable.
• Experience with excel / metrics generation is desirable.
• Strong communication and organisational skills required.