PbMake your mark for patients /b /ppWe are looking for a bQuality Pharma Specialist /b, who is eager to join our bQuality team /b, based in our manufacturing site in bBulle, /b bSwitzerland. /b /ppbAbout the role /b /ppAs a Quality Pharma Specialist, you are responsible for compliance activities and quality strategies relating to products delivery (Production, Supply Chain, Technical Services, Quality, Business Acceleration) in compliance with national and/or international regulations, guidelines (GMP), and relevant UCB Quality Policies. /ppbWhat you’ll do /b /pliProvide quality support related to product delivery from start to finish for the product(s) in charge, including management of activities and processes related to: /liliDeviations, OOS, CAPAs, Change Control, Complaints, /liliEquipment’s/Utilities/Environment qualification, /liliProcess/Cleaning validation, Product Quality Review, Continuous Process Verification, /liliMaster data activation, /liliGxP documentation. /liliEstablish and maintain relationships with internal/external customers/stakeholders to provide efficient follow-up of product related to deviations, change controls, investigations, incidents, CAPA, complaints, etc. /liliEnforce Compliance of stakeholders related to relevant product flow, UCB standards, and GxP. /liliEnsure through procedures that equipment/process are qualified/validated according to current Guidelines. /liliLead and/or participate actively to internal audits/inspections according to annual planning. /liliContribute to the redaction and/or approbation of SOPs, Methods, Specifications, Master Batch Record, etc. /liliActively contribute to Product Quality Reviews (PQR), Continuous Process Verification (CPV); and to investigations as needed. /liliPerform Batch record review and Release/Reject activities as needed and as delegated by the RP. /lipbI /bbnterested? For this role we’re looking for the following /bbeducation, experience /bband /bbskills /b /pliMaster’s degree in Life Sciences, and/or equivalent working experience. /liliA minimum of 3 to 5 years of experience in manufacturing, laboratory, quality assurance/control, regulatory affairs. /liliAbility to coordinate multifaceted projects and to meet critical deadlines. /liliIndependent and autonomous mindset, working under tight and shifting priorities. /liliAbility to work closely with operational teams in manufacturing and laboratory areas. /liliExcellent negotiation and convincing skills. /liliWell-developed sense of discretion. /liliDemonstrated oral and written communication capabilities with varying, culturally diverse groups and/or individuals and/or functions. /liliDemonstrated understanding of the GxP environment and technical competence in core areas of pharmaceutical product manufacturing. /liliDemonstrated ability to write up scientific/technical documents. /liliExcellent oral and written communications skills in French and in English. /lipAre you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! /p