QA Associate Specialist
Reference: | AMC20711 |
Location: |
Carlow
|
Qualification: | Degree | Experience: | 1-2 Years |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
QA Associate Specialist
AMC20711
Contract – 11 months
Shift role
On site - Carlow
We’re currently recruiting for an exciting opportunity with a multinational Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational at an exciting growth period.
Duties
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Responsible for ensuring manufacturing of drug products is in compliance with cGMP and associated regulatory requirements
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Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
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Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to customers.
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Review and approval of batch documentation, SOPs, cleaning verification and validation data, training and other QMS documentation
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Provide quality oversight including training on all aspects of QMS and GMP and provide quality support for day to day operations
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Participate in Plant/Quality committees to help set the direction for plant wide GMP initiatives
Education & Experience
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Third Level Degree qualified in a Science/Technical or related discipline.
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GMP audit experience in pharmaceutical industry
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Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
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Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
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Report, standards, policy writing skills required.
If interested in this posting please feel free to contact Angela McCauley on +353876930951 or angela.mccauley@lifescience.ie for further information.