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Regulatory Compliance Officer

1 week ago

Stockholm, Stockholm, Sweden Recipharm Full time
About the Job Description

This job description outlines the responsibilities and requirements for the QA Specialist role at RPH Pharmaceuticals.

Key Responsibilities:
  • Manage and maintain our eQMS.
  • Track quality-related issues and ensure actions and tasks are completed on time.
  • Lead GxP training and perform SOP training.
  • Track KPIs for deviations, change controls, CAPAs, change control actions, effectiveness checks, complaints, and training.
  • Perform GAP Analysis of our organisation's SOPs against global SOPs.
  • Create, maintain, and archive GxP documentation.
  • Provide support during MHRA/Health Authority inspections, customer audits, and internal audits.
Requirements:
  • Degree in Quality Management, life sciences, or a related field.
  • Knowledge of GMP and GDP.
  • Detailed knowledge of Good Documentation Practice and Data integrity.
  • Pro-active and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy.
  • Competent knowledge of risk-based approach, used in deviations and risk assessments.
  • Effective planning and time management, organisational skills.
  • Ability to build relationships with key internal and external customers.
  • Proven experience of working to meet high standards and provide excellent customer service.
  • IT literate: Microsoft Outlook, Word, Excel, eQMS.