MSD Associate Director Qualified Person QP 

Ireland 

537304166

Job Description

Qualified Person

Bring energy, knowledge, innovation and leadership to carry out the following:

• The QP will be involved in the review and certification of batches intended for use in clinical trials, to ensure compliance with EU GMP, the Product Specification File and the Clinical Trial Application.
• This role will encompass product manufactured across the company Global Supply Chain and subsequently imported into the EU. Products include Small Molecules, Large Molecules – Biologics, Vaccines, Gene Therapy etc
• The QP will be involved with Health Authority Inspections to maintain the site licences, audits both internal and external.
• This role will also be involved in ongoing compliance activities related to clinical trials, for example technical and quality agreements with collaborators, stock recovery activities etc.

In order to excel in this role, you will more than likely have:

• Eligible to be named as a Qualified Person (QP) and to have maintained CPD
• Practical experience with product types such as Sterile, Nonsterile, Biologics, Vaccine, Gene Therapy orATMP,is preferable. Including at least two years experience in quality assurance or qualitative analysis of related medicinal products.
• A recognised pharmacy degree course at a third level institution in Ireland or if the pharmacy course has been completed outside of Ireland evidence of Pharmaceutical Society of Ireland registration and acknowledgement from the EU competent authority where the pharmacy degree was completed to meet the educational requirements of Article 49 of EU Directive 2001/83/EC and Article 97 of the EU Regulation 2019/6.
• An academic qualification at least equivalent to a level 8 primary course in a scientific discipline and has successfully completed a recognised post-graduate course in Ireland that satisfies the educational requirements as defined in the EU Regulation 2019/6 and the EU Directive 2001/83/EC.
• Extensive experience in a cGMP environment, preferably gained in a Quality function with respect to clinical trials/IMP environment
• Experience with conducting audits and hosting inspections
• Dynamic individual with excellent organizational skills, who can work effectively and proactively on global functional teams
• Effective verbal and written communication skills in collaborating to colleagues and associates both inside and outside the organisation

Current Contingent Workers apply

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