Our client a leading pharmaceutical manufacturing company now have a vacancy for a Head of Quality Systems and Support Department. This is a 12 month fixed term contract.
Key objectives of the role include:
To implement and maintain GMP and validation programmes which comply with Global Quality, current GMP and other regulatory requirements and to drive the sitewide Quality culture To ensure that Quality is an efficiency enabler for the business
Responsibilities include delivery and compliance of the Pharmaceutical Quality System in-cluding associated programmes as follows:
GMP governance and training for the FG Manufacturing (FGM) IE sit GMP documentation management and approva Daily GMP support for FGM IE Departments outside of production areas Quality Management System Reviews and other Quality performance reviews and provision of support for the Annual Product Quality Review process Change Control Internal and external inspection preparation and facilitation Supplier Quality management, as appropriate for the local site Distribution Quality governance, as appropriate for the local site Qualification/validation Quality approval, authorisation and execution of studies managed within the Department Maintenance of the site master file, company licences and provision of Quality dec-larations and other Quality support information for Regulatory Affairs Investigation, deviation and CAPA completion and support for FGM IE as relevant Ensuring adequate local area Quality improvement plans for FGM IE Quality support for projects and project delivery Local department management responsibilities include team leadership, personnel recruit-ment, training, development, departmental goals, performance management and delivery of Quality, Customer Service, Cost and other key targets.
Applicants will possess a minimum of a Chemistry, Biology, Pharmacy or an equivalent third level degree qualification At least three years' experience in a Quality or Production function within the pharmaceutical industry. "Qualified Person" status under EC Directives and/or experience of Medical Device Quality Systems along with previous supervisory or management experience could be advantageous. Excellent knowledge of Pharmaceutical Quality Systems, manufacturing processes and other relevant support and control systems is required.
For more information and to apply for this role please call Linda on 1 or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1