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Quality assurance systems manager

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

P BELIEVE IN LIFE. Join a company that takes you further! /pp Galenicum 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. /pp People 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. /pp Here’s the lowdown on what your role will actually look like (spoiler alert: it’s awesome!) /pp We are looking for a Quality Assurance Systems Manager. What you'll be rocking: /pulli QA system activities, for SOPs maintenance and updates, based on current procedures in place in the company. /lili Management of suppliers. Coordination and Implementation of supplier evaluations. /lili Organization and implementation of Internal audits. /lili Proposal and management of corrective actions with focus on continuous improvement. /lili Management of validations (transport, software) including Validation Master Plan performance. /lili Keep updated on GMP regulations and evaluate the impact within our own Quality System and activities. /lili Lead, manage and ensure proper GMP/GDP training throughout the company. /lili Ensure that GMP requirements and quality standards are recognized, understood and maintained across the Company. /li /ulp What you bring to the table: /pulli Excellent level of knowledge of EudraLex Volume 4-cGMPs Guidelines, including cGDPs, GLP and FDA Guidelines. /lili Experience in implementing Quality Systems in a GMP environment and direct experience with Health Authority Inspections. /lili Experience in MS Office. /lili Experience in SAP. /lili Experience in TrackWise or similar platform. /li /ulp Educational milestone: /pulli Degree in Pharmacy or life sciences /lili Master’s degree in Pharmaceutical Industry or related. /lili Excellent level of English and Spanish, spoken and written. /lili Auditor training and experience /li /ulp Your key superpowers: /pulli Motivated, disciplined, proactive, dynamic, methodical, organized and decisive. /lili Self-sufficient, influencing, leadership and management skills. /lili Strong analytical and critical skills to troubleshoot complex problems. /lili Highly responsible and capable to work under pressure to meet deadlines. /lili Ability to prioritize multiple tasks. /lili Good team player and collaborative working style with the ability to build partnerships with key stakeholders. /lili Excellent organizational, planning and time management skills, to achieve project timelines. /lili Detail oriented professional with strong written and oral communication skills. /lili Report redaction (risk assessment evaluation report, audit report, among others). /li /ulp We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you? /pp Come aboard. Believe in life /p

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