Contracting – Brabant Wallon BACK-UP FUNCTION The position can act as back-up for his direct colleagues after appropriate training OPERATIONAL QA ROLE Assure that intermediates and active pharmaceuticals products get produced and released in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH) Follow up of product related: change control, failure investigation, deviations, CAPA and action plans, qualification of dedicated equipment (protocols and reports) Review of batch record from intermediates to drug substance Batch disposition of chemical intermediates (DS manufacturing) Review of master batch records and specifications CONTINUOUS IMPROVEMENT Support the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the site. Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projects Promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BPM and related supporting services Ensure general cGMP training of internal customers Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements Ensure communication of compliance status and issues to appropriate levels of the organization Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BPM and related supporting services Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections Min 3 years experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health related field Experience with Chemical/ pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industry Experience with Quality Management System Ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision Excellent team player attitude with excellent interpersonal relationship and communication skills Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings Fluent in French and English Jefferson Wells offers you a permanent cont... FDA, Protocols, Pharmaceuticals, Prioritize Workload, Process Equipment, Process Management, Manufacturing, Masterbatch, Investigations, Projects, Development, Ability to Plan, Support Network, Internal Customers, Communication, System Process, Leadership, Operations, PIC, Technical work, Quality assurance, Equipment support, Pharmaceuticals, Support Systems, Communication, DS, Health System, Communication, Exploit, Audit Observations, Risk Identification, Quality assurance, Inspection, Regulation, Pharmaceuticals, Investigations, Training, VOS, Quality Control, EMEA, cGMP, Best Practices, Life Science, Direct support, Management, Disposition, Production, Service, Change Control, Accountability, CAPA, Batch Records 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! Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be! La version originale de cette offre d'emploi est disponible sur stepstone.be – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves ! https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be!
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