Snr Quality Sys Spec. (Change Control)

Careerwise Recruitment

Limerick

SENIOR QUALITY SYSTEMS SPECIALIST - CHANGE CONTROL role with our BioTech client in the Mid-West, this is a permanent role. The SENIOR QUALITY SYSTEMS SPECIALIST - CHANGE CONTROL will co-ordinate and maintain the site Change Control process to ensure that this key element of the Quality Management System continuously operates in a compliant manner while meeting ongoing business requirements. The role may also involve supporting other quality system elements such as Deviations, CAPA or QRM as required. THE ROLE: * Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management. * Primarily responsible for administration and oversight of the Change Control process but may also be responsible for one or more of the site quality systems including but not limited to; Deviations, CAPA & Quality Risk Management. * Responsible for review and approval of associated change control documents, and other documents such as: Failure investigations, corrective/preventative action documents & Standard operating procedures. * Maintaining the electronic systems used for Change Control, Deviation Management and CAPA. * Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements. * Provision of monitoring and trending metrics associated with change control and other site quality systems. * Actively participate in continuous improvement initiatives. * Participates in regulatory and customer audits. * Participates in quality risk assessments. * Collaborates with functional departments to resolve issues and maintain compliance. * Identify gaps in systems and develop feasible plans for correction. * Training of personnel on change control and other quality system processes. REQUIREMENTS: * Requires BSc/BEng in scientific discipline or related field with 6 years of relevant work experience in pharmaceutical or related industry. Please call Conor Twomey today for further information on 021-4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2239 days ago