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Contact Info
Karen Shiel
Life Science

+353 1 5079256
karen.shiel@lifescience.ie
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Details

QA R&D Senior Manager


Reference:KS/ASJR-215408 Location: Waterford
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Manager, QA Supervisor, QA Manager

Our client is a leading Pharmaceutical organization based in the South of Ireland. They are currently seeking a QA R&D Senior Manager who will be responsible for quality aspects and support for Inhalation Product Development activities. The successful person shall give QA support for both our client in Ireland R&D CMC activities and also New Jersey Device Development activities. They will play a key role in quality management; maintain the quality systems at both sites and ensure compliance with relevant EMA, FDA and other GMP regulations, as well as with our clients corporate policies and standards, in support of GMP manufacturing and testing for Inhalation products. They will also oversee QA of vendors supporting development and manufacture of Inhalation products. The position could potentially include management of the QA team located at NJ USA in the future.

Role/Responsibilities:

  • Final batch release of clinical batches, including review and approval of batch manufacturing records, packaging records, COAs and associated documentation.
  • Review and approval of specifications and other relevant CMC documents.
  • Review and approval of validation protocols and reports.
  • QA oversight of laboratory activities including review of analytical data, protocols and reports.
  • Review and approval of change control for changes to systems including facilities, utilities, equipment, laboratory instruments, test methods, raw material, intermediate and finished product.
  • Review and approval of investigations, deviation reports, and CAPAs.

Education / Experience:



  • Minimum Bachelor’s degree from an accredited Institute in a scientific field, preferably Chemistry
  • Master’s degree or PhD preferred.
  • Experience in a pharmaceutical company.
  • Experience in GMP QA.
  • Experience in Inhalation products an advantage.
  • Managerial experience and capabilities.
  • Capable of operating globally.
  • Willingness to travel when necessary.
  • The position is located at their south of Ireland facility and requires on-site presence to fulfill job requirements and duties.


If you would like further Information you can contact the recruiter directly:

Karen Shiel | Tel: +353 (0) 1 5079256