QA Validation Specialist
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2969 |
| Job Views | 1620 |
- Description
- Team Horizon is seeking a QA Validation Specialist for our Client who are based in Dublin.
Why you should apply:
Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.
Be part of a diverse and dynamic team
What you will be doing:
Routine POMs recipe validation and QA support.
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.
What you need to apply:
Bachelor's Degree required in a scientific or engineering discipline.
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.
