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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Manager/Senior Manager QA Operations


Reference:SCAYSO-602358 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person, Quality Manager, Quality Specialist

Manager/Senior Manager QA Operations
Our client, a growing Biopharma organisation are currently recruiting for a Manager/Senior Manager QA Operations to join their team on permanent basis. As Manager/Senior Manager QA Operations you will beresponsible for overseeing a QA team and their projects.

Responsibilities

  • Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions; Master records, executed records, failure investigations Change Controls, SOPs, Validation protocols and summary reports and Incursions
  • Approve various documents relating to area function
  • Organize QA resource assigned to functional area to meet goals and timings; coordinate prioritization of activities with area management
  • Perform compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions
  • Review customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality
  • Participates in regulatory and customer audits & liaise with customer/partner quality organizations
  • Participates on internal committees/teams
  • Provides advice and direction to other company departments on quality and regulatory issues
  • Acts as an auditor on behalf of the organisation

Requirements

  • BSc in Life Sciences discipline or related field (chemistry, biology, or pharmacy preferred) with
  • Experience in a pharmaceutical/biologics manufacturing environment desired.
  • Minimum 7 years’ experience in pharmaceutical industry with 2+ of those years to include leadership and/or supervisory experience
  • Eligibility to act as a Qualified Person (QP) in accordance with EU directives preferred.
  • Experience in start-up operations an advantage