Our client, a leading pharmaceutical company based in Limerick currently has a Senior Quality Compliance Specialist to join their team.
This is a full time, permanent position offering an excellent salary and benefits package.
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.
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.
Administration and oversight of site quality systems including but not limited to; Deviations, CAPA, Change Control, Audits, Customer Complaints, Quality Risk Management
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
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 requirement
Provision of monitoring and trending metrics associated with 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 quality system processes
Education and Experience :
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.
For more information on this position please call Lee-Ann Enright on 061 336136 or apply online and a member of the Harmonics team will be in touch