PART TIME QP
The responsibilities of the Qualified Person (Biologics) include the following:
Management of batch disposition and material status control activities associated with Advanced Therapeutic Medicinal Product 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 ATMP 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.
Participation in the site Internal Audit programme.
Participation in the preparation of, and hosting, external cGMP audits
Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
Acting as a designee to the QA Manager as required.
EDUCATIONAL REQUIREMENTS FOR THE JOB:
Primary Degree in a scientific discipline
Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.
RELEVANT EXPERIENCE REQUIREMENTS FOR THE JOB:
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.
Please review the requirements for this role and apply to Clara Henry on firstname.lastname@example.org or phone 01 4744676 for more detail.