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Details

Qualified Person QP


Reference:AKBH-001560 Location: Carlow
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

Qualified Person QP
Our client is a global manufacturer of biopharmaceutical products are currently recruiting for a Qualified Person (QP) to join their team on a permanent basis. AsQP, you will be responsible for ensuring that the process for the manufacture of drug product at is in compliance with cGMP and the associated regulatory requirements.

Responsibilities
• Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations
• Provision of advice on all aspects of Regulatory GMP practices and systems
• Design, develop and deliver training courses for QA/QP function on aspects on aseptic processes for finished pharmaceuticals
• Actively participate in Plant/Quality committees and works with other site functional groups, such as the Production and Maintenance to help set direction for GMP initiatives
• Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends
• Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site
• Support the introduction of new products onto site in relation to Quality oversight, covering the end to end product release strategy

Requirements
• 2+ years' experience of working as a releasing QP IN Drug Substance and/or aseptic filled pharmaceuticals
• Knowledge of EU/US quality related pharmaceutical regulations
• Experience of conducting quality based investigations and root cause analysis
• Provide quality input to ensure batch impact is properly assessed
• Work with cross functional team including technical SME's to ensure that appropriate corrective and preventative measures are assigned
• Qualified Person requirements as defined in EC directive 2001/83/EC and 2001/20/EC


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

Sinead Cullen | Tel: +353 (0) 1 507 9252