Senior QA Specialist

Cork  ‐ Onsite
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Description

My Client is seeking a Senior QA Specialist who is looking to progress their career and proactively lead Quality on site for all stakeholders. If you are unconventional, relentless and passionate, if you are a doer and have a passion for leading Quality then this is the role and company for you.

Working with a large product portfolio and constant new product introduction on site the Senior QA Specialist will have the following responsibilities:
  • Responsible for product release, the Senior QA Specialist must ensure that each batch released of DPI is manufactured and tested in accordance with the current EU/FDA GMP Directives and the relevant marketing authorisation.
  • The principles and guidelines of GMP as stated in Directive /EC and as interpreted in the EU Guide to GMP have been followed.
  • Review of documentation from Quality Control, Manufacturing and Packaging operations for release.
  • To assess all Quality related issues and provide direction to relevant departments to allow efficient resolution of these issues.
  • To support the implementation of the Operational Excellence programme on the site by leading and implementing improvements in the QMS.
  • Provide advice and guidance on all regulatory matters across all functions.
  • The Senior QA Specialist will take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting batch release of products manufactured by the company for a customer.
  • Act as the lead in internal and external audits to ensure a successful outcome.
  • Act as the Quality lead with all customers.
  • To act as change agents by gaining support for and driving sustainable improvements to ways to improve Quality on the site.
  • Ensure compliance with all Quality guidance.
  • Any other duties as assigned by the Quality Director/ QA Manager & QP.


Education and Requirements:
  • Third level qualification in a science related discipline or a Pharmacist.
  • Qualified Person status / or eligibility to become a QP.
  • Strong organisational skills with the ability to multitask and prioritise workload.
  • Excellent interpersonal and communication skills.
  • Experience in API pharmaceutical manufacturing is essential.
  • Experience in DPI and DP would be advantageous but not essential.
  • An understanding of, or exposure to Lean Manufacturing and Project Management methodology techniques would be an advantage but not essential.
  • Proficiency in speaking, comprehending, reading and writing English is required.


This fast paced CMO environment will allow you to fully explore your abilities and talents.

For immediate consideration please apply below with an up to date CV. Not Sure yet? No CV at the Ready? Have more questions about the role? Give me a call Anna Mooney .
Start date
04/2016
Duration
Permanent
From
Real Staffing
Published at
18.03.2016
Project ID:
1094010
Contract type
Permanent
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