Brabant Wallon Contracting As a QA Release Specialist, you will develop, assure and maintain the quality of the product and processes: Standard procedures Quality audits/review Key Performance Indicators (KPIs) Process re engineering Raises and maintains the status of quality in the organisation. Enables a company to promote itself as one that provides quality goods and service. Involves Total Quality Management (TQM) programmes and the development of standard procedures in accordance with GSK standards and cGMP Regulations. Drives and leads the release process for the area of responsibility (Submission final products intermediate products raw materials) for Belgium, International biosites and CMO''s. Ensures the release of products and raw materials in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements. Represents QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC follow up meetings, ICG project, ). Acts as a Subject Matter Expert (SME): (= knowledgeable of the QMS standard related to the area of expertise, ensures all requirements of the standards are cascaded in SOP''s, accountable for gap analysis and related action plans). Is a key spokesperson during regulatory inspection Performs internal audits. Manages and reviews Quality Reviews. Ensures and prepares the release of batches for the official control laboratories in a timely manner. Ensures timely escalation of quality issues, manages and reviews deviations, complaints, change controls in a timely manner. Manages technical/release problems and evaluates potential impact on product quality. Leads a small team of technicians. Lead transversal projects and process improvements. Key spokesperson during regulatory inspection University degree in sciences: Pharmacist, Bio Engineer, Biologist, Chemist At least 5 years professional experience from which at least 3 years in a GMP Environment related to pharmaceutical production with preference to aseptic. Good knowledge of cGMP Fluent in spoken and written English, including presenting and negotiating Expertise recognized in several fileds related to release system. Jefferson Wells offers you a permanent contra... Universities, Expertise, Area responsibility, GMP, KPI, Science, SME, Staff Meetings, Laboratory Work, Projects, Inspection, Negotiation, Development, Regulation, KPI, Raw material, Quality audit, VOS, Internal Auditing, Quality Reviews, cGMP, GMP, Write English, ACT!, RPC, Gap Analysis, Cascade, Knowledgeable, Service, Product Quality, Change Control, Quality assurance, Marketing, CAPA, Process Development 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 carrieretips op StepStone.be! Original job ad is published on StepStone.be Set up a Jobagent at StepStone now and f