Validation Manager. The Validation Manager will be responsible as Process Owner for the Validation Process within Immunoassay, Clinical Chemistry, Haematology and Professional Services areas. The responsibilities of the role are to manage and oversee the process to ensure compliance with the relevant regulatory requirements. This position is a Divisional role and reports to the Quality Director. Job Responsibilities. Key Quality and Manufacturing Process Owners are responsible for the oversight and continuous improvement of their process globally. Act as the Document Owner and can act as Document SME for all global documents associated with the process (e.g. Process-level documents and Learning materials. Perform periodic review as defined in Operating Procedure Q05.01.011. Ensure that the process remains current, complete, and compliant with the company Policy documents and external regulatory requirements as defined in Operating Procedure Q01.12.001. Review all proposed changes as appropriate with the Process Community. Assemble PO/PC Metrics per internal Form 08001 requirements for Management Reviews. Oversight of global investigations and associated corrective/preventive actions. Analyse Tracking and Trending of Nonconformances that have exceeded control limits. Provide support for Nonconformance and Corrective and Preventive Action (CAPA) process as defined in Operating Procedure Q14.14.001. Identify potential Quality Plan projects. Assess documents and Learning Materials for process improvements. Lead process improvement projects. Establish annual goals and strategic direction of the Validation Process Community. Ensure open channels of communication and alignment on approach with ATM Validation Process Owner. Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to. This position does not have any permanent direct reports but may be required to supervise individuals or teams on an as needed basis. Elevate any areas of potential risk as appropriate mapping out options, risks and recommended path forward. Complete a monthly summary and detailed report for area of responsibility covering achievements, updates, risks. Candidate Requirements. Bachelor’s degree preferably in technical/scientific/engineering discipline. Minimum 5 years’ experience in Quality or Technical role preferably in Management/Supervisory role. Minimum 5 years Medical Device Industry experience in validation. Validation SME knowledge. Results driven with a collaborative style and positive attitude. Experience of working in a matrix organisation and liaising with cross-functional teams. Excellent communication and interpersonal skills with an ability to effectively manage all stakeholders, including effective conflict resolution. Proven track record of proactively seeking feedback and driving continuous improvement. Demonstrated experience of effective decision skills. For an immediate interview please forward your CV using the apply button. Or call Megan Warr on 091507515 for a confidential conversation. Visit www.cpljobs.com for more Engineering jobs.
64 days ago