Job Type: Perm
Job ID: JO-2002-22122
Consultant: Karen McHugh
Are you a QP with pharma experience in sterile manufacturing ?
Would you like to work for a multinational Biopharmaceutical company based in Dublin?
Qualified Person - QP - Biologics - Dublin
Our client is one of the world's largest Pharmaceutical and Biotechnology companies and has multiple manufacturing sites across Ireland.
With major capital investment happening in their plants, this is an exciting time to join the team.
You will be a key member of the Quality Assurance team on the sterile manufacturing site
Responsible for promoting a culture of Regulatory Compliance and Continuous Improvement
Management of batch disposition and material status control activities associated with Products acting as a Qualified Person.
Management of review of Batch Manufacturing Records (BMRs).
Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
Management of the Change Control process associated with Cell Therapy manufacture and testing, ensuring controlled implementation of all GMP changes.
QA oversight of routine manufacturing, testing and relating activities to ensure on-going cGMP compliance.
Implement KPIs within the Quality Assurance area to align with company and global quality objectives.
Participate in the site Internal Audit programme.
Prepare documentation for regulatory submission and participation in regulatory affairs discussions.
Take a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
Primary Degree in a scientific discipline
Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.
Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.
Experience of sterile manufacture is essential.
Experience of biologics manufacture is desirable.
Total Package €90k - €120k
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you are a QP interested in roles based in Dublin, you can contact Karen by e-mail firstname.lastname@example.org or phone +353-1-7978720 for a confidential chat.
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