Contracting – Brabant Wallon Operational Provide timely and efficient GMP/GDP IMP Release function to all relevant company's project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…). Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc.. Support the systems and processes in place for the appropriate documentation of company's development activities and to maintain them in a manner compliant with regulatory and corporate requirements. Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house). Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement). Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions. Provide support in the evaluation of Temperature excursions for IMP. Management of Quality Complaints of IMP. Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits. Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…) Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements Contribute the preparation of audits (internal/external, regulatory inspections) Lead internal audits / Self-Inspections Process Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant). Support the Head of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities. Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions. Ensure Clinical supply Quality processes directly support Technical Operations and development partner goals and objectives. Review and QA approval of deviations, change controls and complaints. Master's degree in analytical chemistry. Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese) QA/compliance experience in pharmaceutical regulated environment Function effectively with minimal supervision Good teamwork and project management skills. Must have strong, organization and analytical skills. Must be fluent in English, other languages are a bonus Facilitator, influencer and planner Fact based decision maker: understand complex issues and have the ability to contribute to informed decision making when working on “grey” issues Able to make/influence quality/compliance decisions in a CMC development environment. Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems) Experience of participation in failure investigations Fami... FDA, Audit, GMP, Documentation, Support Systems, Quality Improvement, Maintenance, Problem Management, Health System, Internal Auditing, Business, Innovation, Decision Making, Manufacturing, Package development, Project Management, Projects, Manners, Inspection, Project activities, Development, Regulation, Pharmaceuticals, Investigations, Self-inspection, Team support, Pipelines, Quality systems, Health & Safety, Risk Analysis, Evaluation, Editing, Leadership, Audit Preparation, EMEA, cGMP, Operations, Government Agencies, Packaging, Change Control, Quality assurance, Problem Management, Change Management, Distribution, Process support, Vendors, CMC Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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