Head Of Quality Systems- Dublin

ICDS Recruitment

Dublin South

Head of Quality Systems-Dublin. (12 month contractrole. 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 site wide Quality culture. To ensure that Quality is an efficiency enabler for the Pharma business. Responsibilities include delivery and compliance of the Pharmaceutical Quality System including associated programmes as follows: GMP governance and training for the Manufacturing site. GMP documentation management and approval. Daily GMP support for FGM 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 declarations and other Quality support information for Regulatory Affairs. Investigation, deviation and CAPA completion and support as relevant. Ensuring adequate local area Quality improvement plans. Quality support for projects and project delivery. Local department management responsibilities include: team leadership, personnel recruitment, training, development, departmental goals, performance management and delivery ofcompany Quality, Customer Service, Cost and other key targets. the deparment works alongside the local Quality Process Stream Department focusing on product release activities, in order to manage site GMP activities. Personnel from Quality Systems and Support also work with Quality Departments at othermanufacturing sites to ensure harmonised Quality structures, systems and processes. The Head of Department will participate in the Quality Management team and will also interact with Global Quality and Quality personnel at other manufacturing sites and Affiliate offices. Youwill be committed to and supporting of continuous improvement initiatives which are endorsed by Global, local Quality and Site Operations Management teams and will also ensure that LEAN principles are adopted and continuous improvements delivered, within own Department, to drive further process optimisations and efficiencies. Applicants will possess a minimum of a Chemistry, Biology, Pharmacy or an equivalent third level degree qualification with 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. The successful candidate will be a demonstrated self-starter, with a hands-on approach, who has excellent organisational, interpersonal and teamwork skills and the capability to commit and deliver to tight and multiple deadlines in a dynamic, challenging work environment. This job originally appeared on RecruitIreland.com.

2828 days ago