QA Validation Specialist

AbbVie

Dublin, Ireland

Job Description

This position, reporting to QA Operations Manager will support the Quality Assurance Validation team based in AbbVie North Dublin. Their primary focus will be to enhance and maintain the quality oversight and compliance systems of validation activities on the Clonshaugh site. This position will primarily be involved in supporting and coordinating day to day activities in the areas of Software Validation and routine POMs QA support. Other activities will include cleaning, facilities and equipment validation and participation in knowledge transfer activities to become a QA Subject Matter Expert on new and developing processes. The position will also support the maintenance of the site equipment calibration programme and ensure that equipment performance is continually demonstrated.

Job Responsibilities:

Author, review, issue IQ/OQ/PQ protocols for software, equipment and facilities and report on executed protocols, as required.
Develop cleaning validation protocols and reports to ensure compliance with regulatory requirements post cleaning activities.
Assist in the management of the site Validation Master Plan and its timely execution.
Participate as a SME providing quality oversight and regulatory advice for projects with other departments such as Engineering, Pharm. Tech, Equipment Maintenance, Manufacturing, Facilities and QA Process Support.
Act as a site contact for vendors where required, including off-site meetings where applicable (e.g., F.A.T).
Provide QA support for Laboratory equipment qualification. Review and approve protocols and reports.
Maintain the site equipment calibration programme and ensure equipment performance is continually demonstrated.
Track and report performance of on-site calibration program.
Contribute to the execution of feasibility studies.
Review and contribute to the development of User Requirement Specifications.
Provide a review and approval of all vendor supplied documentation.
Generate/contribute to risk assessments as required.
Author documents that ensure cGMP compliance, such as Standard Operating Procedures, investigations, CAPAs, reports and forms.
Seek process innovation and continuous process improvement in QA Validation area.
Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures.
Maintenance of a system to ensure current equipment and cleaning validation status information is supplied for the completion of Annual Product Quality Reviews
Provide direct support during competent authority audits.
Assist in conducting internal self-inspections and external audits as appropriate.
Assist in maintaining the site validation document archive system.
Perform assigned tasks in accordance with procedural requirements and scheduled timelines. Notify supervisor and other impacted stakeholders if procedural requirements or timelines are not being met.
Carry out and assist in the on-going training of new and existing personnel, as appropriate.
Perform other related duties or projects as assigned.

Qualifications

Bachelor's Degree required in a scientific or engineering discipline. Engineering degree preferred.
Minimum of 5+ years' experience in the pharmaceutical industry with excellent working knowledge of cGMP and Solid Oral Dosage is required.
Strong analytical skills combined with the ability to trouble shoot and knowledge of FDA/EMA regulatory requirements essential.
Good communicator both verbally and written with strong interpersonal and excellent organizational skills.
Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation knowledge and/or experience is preferable.
Experience with POMs, TrackWise, eDocs and SAP are preferable.
Excellent Protocol/Report writing skills are required.

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