QA Manager For Sff
CPL
WATERFORD
Quality Assurance Manager for Sterile Fill Finish. On behalf of my client, I am recruiting for a Quality Assurance Manager for Sterile Fill Finish. The successful candidate will manage a team of 3 direct reports to begin with, and possibly expand this team further. This QA Manager will be responsible for all aspects of the Sterile Fill Finish QA team and provide leadership and support to direct reports. Key Responsibilities: Support the Head of Quality and maintain the companys Quality System. Ensure all work carried out is compliant with company standards, cGxP, SOPs, regulation and guidelines, safety and environmental guidelines. Collaborate across all departments and represent Quality on the Sterile Supply Value Stream. Batch documentation review ensuring compliance to standards and SOPs. Batch package preparation for QP release. Manage Vendor Qualification. API and excipient disposition. Involved in the recruitment, leadership and career development of Quality Assurance members. Creation of Quality department goals aligned with site strategy and objectives. Qualifications/Experience: Primary degree in a relevant scientific discipline. Minimum of 8 years experience in the Biopharmaceutical industry, at least 5 of which should be within a Quality function. Minimum 4 years of leadership experience, including team development. Experience of Quality Assurance of aseptic medicinal products and in particular biopharmaceuticals. Experience in using lean methodologies and / or operating within Value Streams. Extensive knowledge of electronic QMS systems EDMS, ERP, TrackWise etc. Experience preparing and hosting Customer & Regulatory Inspections. Lead auditor experience. Knowledge of electronic document management system and electronic deviation / CAPA systems. Excellent project management, planning and organisational skills. Additionally: Candidate is eligible to act as a Qualified Person as described in EU Directives, would be an advantage. If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email cphillips@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com.
1394 days ago