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QA, Compliance

Job title: Contractor Compliance Specialist (w/m/d) Industry: Biotech Skills: QA,Compliance Start of project: 01.08.2023 Duration of the project : 12 months Project volume: 100% Location: Visp The Compliance Specialist, reporting to the Compliance Lead, is responsible to ensure GMP Compliance of the site.  These are monitoring, trending, reviewing of compliance critical functions including quality systems, change control, training, internal audit, document control, deviation, corrective and preventive actions, regulatory and customer audit program for the site. The Compliance team supports day to day quality activities in accordance with approved procedures/policies on the site. Quality Compliance: Monitor Quality Performance and trends Quality Events of the site. Serves as the Trackwise Administrator / Subject Matter Expert for the site. Work with the Compliance Lead and other Department Managers to ensure timely closure of all quality events such as change controls, non-conformances, investigations, corrective / preventive actions (including audit commitments), and effectiveness checks. Analyze and present Quality related metrics reports, data and Key Performance Indicators (KPIs). Investigate non-product related non-conformance with the required personnel / department on site to develop CAPA and effectiveness checks. Frequent review into the Quality Events to ensure the Quality Events are completed to the level as required. Participate in the Quality Risk Management Program and Assessment. Work with the Quality Risk Management team to develop Quality Risk Assessment Reports. Work with the Compliance Lead to evaluate new Lonza Global Quality Standards, and implement locally where appropriate. Participate in the internal audit programs as internal auditor, when required. Provide training in key areas of Quality System performance and compliance to continuously improve overall knowledge of the site in quality systems and develop behaviors that contribute to GMP activities. Maintains the GMP documents in the Documentum in a GMP compliant manner People Communication: Communicate potential quality risks / issues based on trends / observations to the management team. Continuous Compliance Improvement: Support in the Development and maintenance of Department Policies, SOPs, and other documents to ensure compliance to the Global Quality Standards. Work with team members and department managers to evaluate and identify gaps on regulatory guidelines. Identify improvement opportunities in the Quality Compliance related areas. Perform the improvement related activities when required.