Quality Assurance Manager

Apsida Life Science have partnered with a leading biotech and research company to present the following role:Job Title: Senior QA Manager GMP/GDPLocation: Basel SwitzerlandContract : 24 monthsCompany Overview:The client company is a biopharmaceutical company that focuses on developing and commercializing medicines, particularly in the cardiovascular field and immunological disorders.Responsibilities:Provide GMP/GDP quality assurance expertise during development and commercialization of Idorsia’s productsEnsure all required quality activities are initiated and completed according to the development stageEnsure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standardsFor assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as neededEstablish a quality risk management approach in projects based on six sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycleManage all required activities to support release of active ingredients, commercial products and/or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controlsNotify CMC team and management of potential quality, regulatory and lead time issuesParticipate, represent and defend quality activities in CMC team meetingsPreparation of GMP/GDP Agreements in collaboration with CMOs and the CMC teamWrite, review, and/or approve internal SOP’s and other GMP/GDP related documentationSupport review and optimization of the company's pharmaceutical quality system by preparing review of relevant CMO's Key Performance IndicatorsRelease of DS and DP Bulk as defined in the relevant release SOPsQualifications:University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum5 years of experience in different positions like pharmaceutical product development/ quality control / analytical development / chemical production or similar operational positions in the pharmaceutical industry5 years of experience in quality assurance of drug substance and/or drug productKnowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distributionGood knowledge of (c)GMP/GDP’sAbility to interpret and implement Quality standardsAbility to manage complex projects and prioritize workload according to the project importanceIf you are interested in learning more, please reach out to Mufaro Mpofu:mufaro.mpofu@apsida.comwww.apsida.co.ukApsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process