Cache of job #14009314

Job Title

Compliance Specialist

Employer

Brightwater

Location

Munster, Limerick

Description

One of the most dynamic and exciting manufacturing sites in Munster is seeking to add a Quality Specialist to its high performing team and manage Change Control Processes. If you're passionate about science and relish the opportunity to work in a demanding but rewarding environment then this could be the next great step in your career. This role co-ordinates and maintains 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. About the Job. Responsible for ensuring compliance with all aspects of Quality for the 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. About You: BSc/BEng in scientific discipline or related field. 3+ years of relevant work experience in pharmaceutical or related industry. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

Date Added

1833 days ago

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