Clinical Quality Assurance Specialist

5 giorni fa


Milano, Lombardia, Italia Jefferson Wells A tempo pieno
Job Title: Clinical QA Specialist

Jefferson Wells is seeking a highly skilled Clinical QA Specialist to support a pharmaceutical company based in Milano, Lombardia.

Main Responsibilities:
  • Contribute to the development and maintenance of Standard Operating Procedures (SOPs) for clinical trials, ensuring compliance with GCP regulations and company standards.
  • Support the drafting and updating of SOPs for quality assurance activities related to clinical trials and investigations.
  • Plan, coordinate, and conduct GCP audits of clinical trials processes, verifying audit reports and certificates.
  • Evaluate the completeness and appropriateness of corrective action plans, assessing the implementation status of preventive and corrective actions.
  • Support the planning and execution of periodic GCP training, ensuring compliance with regulatory requirements.
  • Assist in the coordination of external consultants for GCP quality assurance activities, ensuring compliance with company standards and regulatory requirements.
  • Support the management in defining, allocating, and managing department projects/initiatives budget, ensuring compliance with company policies and regulatory requirements.
  • Ensure compliance with legal obligations and procedures regarding occupational safety and hygiene, as well as environmental protection, within the area of responsibility.

Key Skills:

  • Strong knowledge of GCP regulations and company standards.
  • Excellent communication and coordination skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
  • Proficiency in Microsoft Office and other relevant software.

Requirements:

  • Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, or a related field).
  • Minimum 3 years of experience in a related field (e.g., clinical trials, quality assurance, or regulatory affairs).
  • Strong knowledge of GCP regulations and company standards.
  • Excellent communication and coordination skills.
  • Ability to work independently and as part of a team.


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