Sr. Quality Systems Specialist

Careerwise Recruitment

Limerick

SENIOR QUALITY SYSTEMS SPECIALIST required by CareerWise Recruitment for our BioTech client in the Mid-West. The SENIOR QUALITY SYSTEMS SPECIALIST maintains site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. 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. * Administration and oversight of site quality systems including but not limited to: Deviations, CAPA, Change Control, Audits and Customer Complaints. * Responsible for review and approval of the following types of documents, relating to area functions: failure investigations, change control documents, corrective/preventative action documents and standard operating procedures. * Maintaining electronic systems used for Change Control and Deviation Management. * 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 site quality systems. * Actively participate in continuous improvement initiatives. * Participates in regulatory and customer audits. * Collaborates with functional departments to resolve issues and maintain compliance. * Identify gaps in systems and develop feasible plans for correction. * Training of personnel on quality system processes. REQUIREMENTS: * Requires BSc/BEng in scientific discipline or related field with 5 years of relevant work experience in pharmaceutical or related industry. * Supervisory experience preferred. * Good working knowledge of electronic Quality Management Systems and associated metric generation preferred. * Proficient at report generation using Excel and other MS Office applications. 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.

2262 days ago