Quality Compliance Manager

Harmonics Recruitment

Limerick

Essential Duties and Responsibilities: •Responsible for ensuring compliance with all aspects of Quality for the site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management. •Oversight of site quality systems including but not limited to; -Deviations. -CAPA. -Change Control. -Audits (Internal and External. -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. - Standard operating procedures. •Approving procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements. •Provision and presentation of monitoring and trending metrics for site quality systems. •Manage and develop site risk assessment activities and site risk register. •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. Education and Experience: •Requires BSc/BEng in scientific discipline or related field with 7+ years of relevant work experience in pharmaceutical or related industry. •Previous supervisory experience is essential. This job originally appeared on RecruitIreland.com.

2743 days ago