Quality Manager

SIGMAR RECRUITMENT

GALWAY

Quality Manager | Galway City. We are recruiting for a permanent Quality Manager for our client, the leading provider of sampling and analysis to the Pharma, Med Device, Food and Environmental industries. You will oversee the Quality and Validation function here in Galway City. Location: Galway City. Pay: Negotiable. Benefits: Excellent salary. Career progression. Reduced and flexible hours will be considered. + much more (enquire for details. Responsibilities of the job: Sustain and advance the Quality System to achieve the highest quality standards attainable. Represent the QC department in regulatory and client audits, ensuring the timely close out of actions/ recommendations identified from all audits. Support the commercial requirements of the business with input and collaboration across business units. Ensure that all policies, procedures and validations are carried out in accordance with cGMPs. Support the commercial requirements of the business through departmental budgeting and business support. Manage analytical method transfers/validation programs in compliance with regulatory/CLS MedPharma requirements. Maintain Quality Technical Agreements with all clients. Perform internal and external audits and manage the internal auditing program. Ensure that data integrity is maintained as per ALCOA+ Author, reviewer and approver of SOPs, analytical validation protocols and reports. Provide analytical/technical support to the analytical laboratory. Procurement of new equipment and coordinate and perform equipment qualifications, executing IQ/OQ/PQ activities and reviewing qualification protocols and reports. Coordinate and perform calibration and maintenance activities on a range of analytical equipment per company procedures and review calibration and maintenance records from peers and external calibration providers. Operate CAPA/deviation and customer complaints and identify and implement continuous Improvement programs as appropriate. Lead a team of analysts in QC by coordinating daily operations and ensuring team members are trained in their job function and current revisions of relevant SOPs. Investigate out of specification results utilizing Structured Problem Solving and Root Cause Analysis tools and implementing effective corrective and preventative actions while ensuring all investigations are closed within the specified lead-time. Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all test-related, Quality Technical Agreements (QTA’s. What we would like you to have: 3rd level qualification in Chemistry or related discipline. 5+ years or equivalent combination of education, training, & experience. Demonstrated knowledge of quality systems, FDA and EU guidelines as they relate to analytical testing. Experience with regulatory inspections. Strong Interpersonal skills and professional skills to interact at all levels including senior management, colleagues and clients. If you are interested in this job and are a suitably qualified and experienced Quality Manager, please contact Aaron Long at Sigmar Recruitment T: +353 91 749 264 | E: along@sigmar.ie. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1527 days ago