Contracting – Brabant Wallon Operational: Provide timely and efficient GMP/GDP IMP Release function to all relevant 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 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. Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…) Ensure adequate QA support for the qualification, validation and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas or laboratories, as well as related cleaning validations. Contribute the preparation of audits (internal/external, regulatory inspections) Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization Ensure and maintain the adequate accreditation for the packaging facilities (CPLO) 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. Eligibility to act as a QP in the EU is essential, with at least five years of practical experience in drug research and development or drug production quality management, including at least one year of drug quality management experience. Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese) QA/compliance experience in pharmaceutical regulated environment Good teamwork and project management skills. Must have strong, organization and analytical skills. Must be fluent in French & English 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. Jefferson Wells offers you a permanent contra... FDA, Review Meetings, Audit, Quality Issues, R&D, Innovation, Manufacturing, Package development, Management, Complex Issues, Informed Decisions, Projects, Project activities, Development, Accreditation, Self-inspection, Pipelines, Quality systems, Problem Management, Communication, Health & Safety, Business Review, Evaluation, System Process, Offering Support, Operations, Government Agencies, Proactivity, Quality assurance, Vendors, CMC, GMP, Documentation, Support Systems, Quality Improvement, Health System, Internal Auditing, Decision Making, Validation, Laboratory Work, Project Management, Manners, Inspection, Regulation, Practicality, Pharmaceuticals, Team support, VOS, Audit Preparation, EMEA, cGMP, Activity support, Packaging, Change Control, Change Management, Distribution, Process support 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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