Quality Assurance Systems Expert

Detalles de la oferta

BELIEVE IN LIFE. Join a company that takes you further 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. 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. Here's the lowdown on what your role will actually look like (spoiler alert: it's awesome) We are looking for a Quality Assurance System Expert to join our team based in Tarragona. What you'll be rocking: Generation of corresponding QA system for a new API continuous manufacturing site in Tarragona. QA system activities, for SOPs generation, maintenance and updates, aligned with current Quality Policy in the company. Management of suppliers, in coordination with corporate management. Proposal and management of corrective actions with focus on continuous improvement. QA support to equipment, services, process and methods implementation. QA review and approval for release of API batches. Keep updated on GMP regulations and evaluate the impact within our own Quality System and activities. Ensure proper GMP/GDP training in the API site. Ensure that GMP requirements and quality standards are recognized, understood and maintained across the API site. What you bring to the table: High level of knowledge of EudraLex Volume 4-cGMPs Guidelines, including cGDPs, GLP and FDA Guidelines. Experience in MS Office. Experience in SAP. Experience in TrackWise or similar platform. Educational milestone: Degree in Pharmacy (mandatory for QP/RP responsibilities) Master's degree in Pharmaceutical Industry or related. Excellent level of English and Spanish, spoken and written. Your key superpowers: Motivated, disciplined, proactive, dynamic, methodical, organized and decisive. Self-sufficient, influencing and leadership skills. Strong analytical and critical skills to troubleshoot complex problems. Highly responsible and capable to work under pressure to meet deadlines. Ability to prioritize multiple tasks. Capable of working under own initiative whilst being a good team player. Excellent organizational, planning and time management skills, to achieve project timelines. Detail oriented professional with strong written and oral communication skills. Report redaction (risk assessment evaluation report, audit report, among others). What makes Galenicum a top-tier workplace? A challenging company, and a dynamic team to work with. A Workspace to enjoy. Pleasant, sustainable, and architecture-awarded office. A flexible schedule to match your preferences and workload. A training offer to learn beyond your job with a broad set of topics: Galenicum Laude. Health insurance coverage to feel cared. Food to keep your energy up. Subsidized meals in our office restaurant Popina. Gym to help you maintain a healthy lifestyle. Flexible remuneration. And, very important A Buddy to help you land smoothly in our company since day 1. We're looking for someone who works hard, plays hard, and laughs harder. Sound like you? Come aboard. Believe in life


Salario Nominal: A convenir

Fuente: Adzuna_Ppc

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