Quality Assurance Manager

hace 1 semana


Esplugues de Llobregat, Barcelona, España Galenicum A tiempo completo

We are looking for a Quality Assurance Manager. He / She will develop the 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 a 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.
  • 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 field.
  • Excellent level of English and Spanish, spoken and written.
  • Auditor training and experience.

Skills :

  • Motivated, disciplined, proactive, dynamic, methodical, organized, and decisive.
  • Self-sufficient, with influencing, leadership, and management skills.
  • Strong analytical and critical skills to troubleshoot complex problems.
  • Highly responsible and capable of working under pressure to meet deadlines.
  • Ability to prioritize multiple tasks.
  • Good team player with a collaborative working style and 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).

Seniority Level: Director

Employment Type: Full-time

Job Function: Quality Assurance

Industry: Pharmaceutical Manufacturing

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