Senior QA Specialist - Biotech

Dublin  ‐ Onsite
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Description

Global Biotech Company is seeking a Senior QA Specialist to join there external manufacturing quality team.

The successful candidate must have experience working within a sterile manufacturing environment.

A very attractive salary and benefits package is offer.

Responsibilities:
  • Assist with the oversight of the supply chain, manufacture and packaging of products in various Contact Manufacturing Organizations.
  • Review of Manufacturing/Packaging batch records and Quality Control records prior to recommending release of batch.
  • Review and approve standard operating procedures (SOPs) and master batch records.
  • Review deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
  • Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
  • Assist with regulatory inspections.
  • Support the following activities, as appropriate:
  • Processing external complaints
  • Quality Deviations and Laboratory Investigations
  • Change Controls
  • New or updates to relevant quality agreements
  • Validation activities
  • Perform Audits internal & external
  • Annual Product Reviews

Education:
  • Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.


Experience:
  • 6+ years experience in a cGMP regulated, sterile pharmaceutical manufacturing and packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
  • Candidate must be willing to travel 20-30% of the time.


If you are interested in hearing more about this great opportunity and would like to hear more about the company and the role please contact me Anna Mooney or apply below with an up to date CV.
Start date
06/2015
From
Real Staffing
Published at
25.03.2015
Project ID:
874495
Contract type
Permanent
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