experience. 2 years’ experience working in a Quality Assurance role. Experience of with assessing telephone calls in a call center is preferred. Deviations andCAPA handling experience. Quality or Six Sigma Certifications are an advantage. Work in a professional manner with clients, team members and management. Analytical skills to gather more »
a high-performing technical operations and MSAT teams. Take an active role in the evaluation of deviations, root-cause-analysis, correctiveactionpreventiveaction (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance. Qualifications: Detailed understanding of immunology and cell therapy. Demonstrable expertise in more »
company standards in relation to GMP - right first-time execution, accurate data, timely close out of Deviation Reporting (DR’s), Correctiveand Preventative actions (CAPA), Change Control, aseptic practices and housekeeping standards. Coordinates or leads investigations in Quality and other loss control incidents in Seed Manufacturing. Ensures compliance with Seqirus more »
drafting of new procedures to enhance the companies QMS. · Support with assessment of deviation event investigations. · Support closure to plan of Change Controls andCAPA actions. · Issue, review and approval of GMP batch manufacturing records to support certification and release. · Assist in performance of internal self-inspection audits. · Support the more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
allocate budgets, staff, tools, and specialized support necessary for efficient operations. Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment. Maintain the CAPAand NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities. Collaborate across the organization at all levels, across functional more »
Hull, North Humberside, North East, United Kingdom
Umbilical Ltd
Participate in the review and approval of GMP documentation, including batch records, SOPs, and change controls. Assist in deviation investigations, root cause analysis, andCAPA activities to address quality issues. Aid in handling customer complaints, conducting investigations, and implementing preventive measures. Support in preparing for regulatory inspections and customer audits. more »
customer, regulatory, internal & compliance audits. Analysis of quality data & generation of quality reports. Support final product disposition & control of non-conforming material. Support the CAPA process, including deviations & customer compliant investigations, ensuring robust root cause analysis & appropriate corrective actions are implemented. Coaching and training of production and technical personnel on more »