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Contact Info
Karen Shiel
Life Science

+353 1 5079256
karen.shiel@lifescience.ie
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Details

Quality Assurance Associate


Reference:KS/HQ00001943 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed


Our client is an international pharmaceutical discovery company, working on inflammatory conditions of the human primary organs including the liver and the lung. They currently have a vacancy for a Quality Assurance Associate. It’s a full time position, office based in South Dublin. Ideal candidate will be a dynamic individual, who is self-driven and capable of working on their own initiative as well as in a team in a fast paced environment.

Role/Responsibilities:
• Manage the Documentation Control process
• Prepare policies and procedures
• Co-ordinate the implementation of the Internal and external audit schedules and ensure the timely completion of audits
• Oversee the effective documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions
• Lead the vendor oversight process, including analysis of Key Performance Indicators (KPIs)
• Review GCP and GMP documentation as required, such as clinical trial protocols, regulatory submission documents and reports
• Conduct audits of investigator sites, vendors and contractors when required
• Generate and maintain Technical Agreements with suppliers and customers in line with relevant regulatory and business requirements
• Ensure that all activities are in compliance with the requirements of Good Clinical Practice and Good Manufacturing Practice.
• Contribute to Company Training procedures as required
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goals of the company

Requirements:
• Scientific degree
• 3+ years of strong GCP experience in the pharmaceutical industry,
• QA auditing experience
• Knowledge of relevant regulatory requirements
• Strong computer skills
• Ability to travel as required
• Excellent communication skills


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

Karen Shiel | Tel: +353 (0) 1 5079256