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QUALITY ASSURANCE SYSTEM MANAGER

Descripción de la oferta de empleo

We are looking for a Quality Assurance System Manager. He/ She will develop following responsibilities:QA system activities, for SOPs maintenance and updates, based on current procedures in place in the company. Management of suppliers. Coordination and Implementation of supplier evaluations.Organization and implementation of Internal audits.Proposal and management of corrective actions with focus on continuous improvement.Management of validations (transport, software) including Validation Master Plan performance.Keep updated on GMP regulations and evaluate the impact within our own Quality System and activities.Lead, manage and ensure proper GMP/GDP training throughout the company.Ensure that GMP requirements and quality standards are recognized, understood and maintained across the Company. Previous experience required:Excellent level of knowledge of EudraLex Volume 4-cGMPs Guidelines, including cGDPs, GLP and FDA Guidelines.Experience in implementing Quality Systems in a GMP environment and direct experience with Health Authority Inspections.Experience in MS Office.Experience in SAP.Experience in TrackWise or similar platform.Education:Degree in Pharmacy (mandatory for QP/RP responsibilities) or life sciences Master’s degree in Pharmaceutical Industry or related.Excellent level of English and Spanish, spoken and written. Auditor training and experienceSkills:Motivated, disciplined, proactive, dynamic, methodical, organized and decisive.Self-sufficient, influencing, leadership and management 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.Good team player and collaborative working style with the ability to build partnerships with key stakeholders.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).
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Detalles de la oferta

Empresa
  • Galenicum
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 25/12/2024
Fecha de expiración
  • 25/03/2025
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