Senior QA Specialist-151463

Company
PPD
Location
Europe, Middle East & Africa-Ireland-Westmeath-Ath
Salary
On Application
Posted
01 Nov 2018
Closes
03 Feb 2019
Ref
151463
Senior QA Specialist     Due to continued growth, PPD is recruiting for a Senior QA Specialist to work on a full-time basis at our Athlone Global Clinical Supplies Depot.   Working within the Clinical Supplies Quality Assurance group, the role will be to provide comprehensive QA expertise to enable successful release of all client IMP batches, adherence to the QMS and support for business leaders and QA Management.   Duties will include:  
  • Lead QA projects supporting GxP manufacturing and IMP release
  • Perform complex batch record review and associated documentation review for completeness and accuracy of data.
  • Manage and lead all activities associated with client, regulatory, vendor, quality management system and/or internal and vendor audits and investigations to include: coordination, scheduling, hosting, conduction of audits and review of audit responses
  • Contribute to quality process improvements
  • Develop, update and ensure compliance to procedures
  • Performs root cause analysis. Assists in resolving critical quality issues to include CAPAs, complaints and recalls, and resolves non-critical quality issues such as deviations
  • Generates reports to provide internal management with tracking, trending, informed analysis reports, process improvement data and key performance metrics
  • Assure all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfil client and company requirements
  • Represent department in client and regulatory audits and ensure effective corrective actions
  • Mentor and guide team members

Qualifications

Education and Experience:  
  • Relevant Degree in Science based subject
  • Strong knowledge of EU GMP regulations, 21 CFR 210/211 & 820 regulations, 21CFR11 regulations and international GMP regulations
  • Min. 8 years’ experience in a QA role within GMP environment - Pharmaceutical or Medical Device
  • Possess strong project management skills
  • Proven proficiency in performing vendor and internal GxP audits
  • Ability to handle multiple priorities and deadlines
  • Currently pursuing a QP qualification is an advantage
  • Experience in Biotechnology industry an advantage
We offer a generous salary, medical insurance, life insurance and pension.
We look forward to receiving your application.   #LI-MH1

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