Head of Quality Operations/Qualified Person

On behalf of our client, in the healthcare, pharma, life sciences space, we are currently recruiting for a Head of Quality Operations/Qualified Person. This role will be approx 90% remote, with only a small amount of time on-site.

Purpose:

·      Provide subject matter expertise for EU Good Manufacturing and Distribution Practice (GMDP) – internally and externally for clients.

·      To effectively lead the GMP and GDP Quality Teams

·      To act as a key contact point for clients both current and potential new business

·      To perform the duties of a Qualified Person

·      Together with the other members of the Quality Management Team, input into the Quality Dept’s vision and strategy, and drive these forward to meet business goals

·      Act as point of contact with authorities, in particular HPRA

·      Act as a GMDP SME to assist the Company, its employees, and clients in fulfilling GMDP responsibilities for quality and quality systems. To work cross functionally within the company and clients providing Quality support up to and including Qualified Person, Responsible Person, project management and advice pertaining to GMDP.

QUALIFICATIONS AND ROLE REQUIREMENTS

·      A minimum of 10 years pharmaceutical industry experience or proven experience which demonstrates an in-depth knowledge of quality systems in a GMP environment (essential)

·      Eligible to be named as a Qualified Person on an MIA/MIA-IMP with min 7 years QP experience

·      Eligible to be named as an RP on a WDA(H) (Desirable)

·      Pharmaceutical industry experience and proven experience which demonstrates an in-depth knowledge of quality systems in a GMDP environment and hosting regulatory authority GMDP inspections (essential)

·      Detailed knowledge of GMDP and experience of working as a Qualified Person

·      Detailed knowledge of the key components of Quality Management Systems and performance metrics together with the relevant skills to ensure the system(s) is implemented and maintained to meet regulatory, company and the client’s requirements.

·      Strong leadership and communication skills

·      Ability to work cross functionally with all Company departments and clients and practically apply relevant quality standards and legislation, to ensure that company and client aims, and objectives are met.

For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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