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Quality Compliance Manager Nr ref.: /JOBS.pl We are currently recruiting for a Manager Quality Compliance on behalf of a global pharmaceutical company. The role holder will be required to: Lead the construction, maintenance and continuous development of the Quality Management System to supporting the ongoing requirement of the site QMS requirements Build a team of SMEs to ensure that and effective QMS is maintained on the site Maintain site Audit readiness state Prepare and host regulatory (HPRA, FDA and others) and customer audits/inspections Maintenance of the Manufacturing License, Site Master File and to act as a liaison with Regulatory Authorities where required. Oversee and participate in Internal and External Auditing programme. Ensure that all QMS elements regarding Investigations, CAPA, complaint, trending and recall systems are in maintained in a compliant state and communicated effectively to appropriate personnel Ensure that Quality metrics are accurate and effectively managed for the site Maintenance and upkeep of the Vendor Management programme Act as Qualified Person as per EU Directives 2001/83/EC, 2001/82/EC and 2001/20/EC (including any subsequent amendments) for release of Pharmaceutical Products/Investigational Medicinal Products to the market with respect to License's. Support and execute any other duties as assigned. Select and maintain qualified personnel in all positions, assists in career planning, succession planning, conducts performance reviews and recommends compensation. Communicate regularly with employees and management about company/department plans, new initiatives and progress against goals. Identify and ensure the development of adequate training curriculum for staff, ensures that appropriate training program is successfully maintained and that 'standard work' practices are employed Support the implementation of the Operational Excellence programme on the site by encouraging the team to identify, lead and implement improvements. Comply with company and legislative Environment, Health and Safety requirements. Support and execute any other duties as assigned. Requirements: Degree qualified in a science discipline is required and an advanced degree (MSc or MBA) is desirable. Must be a Qualified Person/Pharmacy or Equivalent Pharmaceutical drug product Manufacturing QA/QP/QC role Must possess knowledge of all applicable regulated agencies that govern the industry. Must possess knowledge of Quality Systems and direct experience leading and managing Quality related functions within the pharmaceutical industry including at least 5 years with management or Supervisory responsibility in quality. Must have technical understanding of pharmaceutical product formulations, and pharmaceutical unit operations. Must understand and adhere to Company and departmental policies and procedures as well as government regulations. Requires understanding of Health Products Regulatory Authority (HPRA) regulations, Food and Drug Administration (FDA) regulations, Current Good Manufacturing Practices (cGMPs), and EU guidelines Must possess good leadership, management, communication, time management, organisational, interpersonal, and writing skills. Ability to work with Senior Management and communicate Compliance requirements effectively For more information and to apply for this role please call Linda on 1 or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1 Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

Ciekawe oferty z tego działu:
Kierowca CE, Walsrode, 2300 EUR netto
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