Vendor Quality Lead

il y a 3 jours

Brainel'Alleud, Wallonie, Belgique Jefferson Wells Manpower Group Temps plein

Job Responsibilities: Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (the company Vendor Team, GQL, ILA, ALO, Business) to allow assessment. Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined tracking tools (Vendor QA KPI tracker, Spider Impact) and track the vendor's performance. Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreements with the vendors up to date and perform periodic reviews and updates of the agreement in close collaboration with the product GQLs and the vendors. When applicable, ensure that the Annual Product Stability Program is rolled out and executed at the vendor in accordance with the company Stability Program. Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and reviewed within the requested time period. Ensure that this review is documented and made available in the company Controlled Documents System. Participate as QA representative in recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings. Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the company Complaint System and provision of responses to the complainant are professionally coordinated and managed. If needed, work with the Vendor team and Global Quality Lead to determine the root cause of issues which may lead to a Corporate Technical Review (CTR) escalation meeting. Participate on an ad-hoc basis in the company Product Change Control Committees for activities related to the vendors. Provide expert QA advice, support, and management for technical operational QA and general QA matters associated with the vendors. Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors. Developer and Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors. Ensure all relevant documentation is provided to the vendors and implemented (Methods, Specs, Master Batch record). Ensure review of relevant RA dossier sections related to the assigned vendors. Have an overview of the company audit and HA inspections related to the vendors. Track and follow up on Audit observations and CAPA plan implementation at the vendor. Be the QA stakeholder for Vendor Risk management. Support customer audits and Health Authority inspections at the vendors, as needed. Receipt, coordinate review and authorize product reworks and repackaging. Be the point of contact for post-release vendor issues (supply chain, distribution, etc.). As required, provide Operational QA support to other vendors. Act as a substitute for other Vendor Quality Leads in times of absenteeism (e.G., vacation, illness). Work in accordance with the company HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development. Your Profile: A Master's degree in Sciences. Fluency in French and English. Must have the ability to independently analyze data and information to draw conclusions and make effective decisions. Must have the ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way. Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective. Our Offer: Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and will give you access to training in technical matters and soft skills. We will be your career partner for each step along the way. You're interested in this job? We kindly invite you to apply or send me your CV at (emailprotected). #J-18808-Ljbffr

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