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  • DUBLIN 2
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  • Job reference number:15276249
  • Client ID:RI/RD16092
  • Posted on:14-SEP-2017
  • Location:WATERFORD
  • Job type:PERMANENT

Quality Assurance Officer - County Waterford

To support the Quality Assurance Manager and ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.
To develop compliance across the site.
To ensure project plans and milestones are delivered according to agreed timelines.

Ensure high quality output – Vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.
Initiate action to correct quality problem and notify others of quality issues as appropriate. If a procedure does not exist, devise one.
To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
To ensure preparation of Submission Documentation in support of licence applications

Mentoring - support company with problem solving and skill development to aid learning and early problem resolution.
Ensure that Vendor Management program is adhered to.

Review batch documentation in a comprehensive and timely manor.
Notify management of any anomalies which could impact the quality, safety of efficacy of a batch.
Ensure Self Inspections are completed as per the defined schedule.
Participate in outside Inspections (Customer audits / Regulatory inspections)
Lead vendor audits of GxP services as required

Minimum Qualifications & Experience:
Four years’ experience working in a Quality Assurance role in a manufacturing environment an advantage.
Lead Auditor qualification an advantage

This job originally appeared on RecruitIreland.com