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Quality assurance systems manager

Esplugues de Llobregat
Galenicum
Publicada el Publicado hace 15 hr horas
Descripción

PstrongBELIEVE IN LIFE. Join a company that takes you further! /strong /ppbr/ppGalenicum is one of the fastest growing companies in the pharmaceutical sector! We are enthusiastic about life, devoting our talent and effort to providing high-quality affordable pharmaceuticals worldwide. /ppbr/ppPeople are the key to our present and future success, so we carefully select candidates that meet the requirements for each position, however most importantly, who also fit with our cultural DNA and values. /ppbr/ppstrongHere’s the lowdown on what your role will actually look like (spoiler alert: it’s awesome!) /strong /ppbr/ppWe are looking for a Quality Assurance Systems Manager. strongWhat you'll be rocking: /strong /ppbr/pulliQA system activities, for SOPs maintenance and updates, based on current procedures in place in the company. /liliManagement of suppliers. Coordination and Implementation of supplier evaluations. /liliOrganization and implementation of Internal audits. /liliProposal and management of corrective actions with focus on continuous improvement. /liliManagement of validations (transport, software) including Validation Master Plan performance. /liliKeep updated on GMP regulations and evaluate the impact within our own Quality System and activities. /liliLead, manage and ensure proper GMP/GDP training throughout the company. /liliEnsure that GMP requirements and quality standards are recognized, understood and maintained across the Company. /li /ulpbr/ppstrongWhat you bring to the table: /strong /ppbr/pulliExcellent level of knowledge of EudraLex Volume 4-cGMPs Guidelines, including cGDPs, GLP and FDA Guidelines. /liliExperience in implementing Quality Systems in a GMP environment and direct experience with Health Authority Inspections. /liliExperience in MS Office. /liliExperience in SAP. /liliExperience in TrackWise or similar platform. /li /ulpbr/ppstrongEducational milestone: /strong /ppbr/pulliDegree in Pharmacy or life sciences /liliMaster’s degree in Pharmaceutical Industry or related. /liliExcellent level of English and Spanish, spoken and written. /liliAuditor training and experience /li /ulpbr/ppstrongYour key superpowers: /strong /ppbr/pulliMotivated, disciplined, proactive, dynamic, methodical, organized and decisive. /liliSelf-sufficient, influencing, leadership and management skills. /liliStrong analytical and critical skills to troubleshoot complex problems. /liliHighly responsible and capable to work under pressure to meet deadlines. /liliAbility to prioritize multiple tasks. /liliGood team player and collaborative working style with the ability to build partnerships with key stakeholders. /liliExcellent organizational, planning and time management skills, to achieve project timelines. /liliDetail oriented professional with strong written and oral communication skills. /liliReport redaction (risk assessment evaluation report, audit report, among others). /li /ulpbr/ppWe’re looking for someone who works hard, plays hard, and laughs harder. Sound like you? /ppbr/ppCome aboard. Believe in life /p

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