Senior Deviations Specialist

Job Summary:

We are seeking a meticulous and experienced Senior Deviations Specialist to support our pharmaceutical company in managing and reducing a backlog of deviations. This role involves processing both existing and new deviations, ensuring thorough review, root cause analysis, and documentation. The successful candidate will lead investigations, collaborate with various departments, and compile deviation metrics to enhance our quality management system.

Key Responsibilities:

• Deviation Processing:
  • Review deviations for completeness and accuracy, ensuring all necessary information and documentation are provided.
  • Draft deviations, facilitating the appropriate approval process and ensuring timely resolution.
• Root Cause Analysis:
  • Conduct thorough root cause analyses for deviations, utilizing structured methodologies to identify underlying issues.
  • Lead and coordinate investigations to determine the causes of deviations and implement corrective actions.
• Documentation and Reporting:
  • Compile and maintain deviation metrics and reports, tracking trends and identifying areas for improvement.
  • Ensure that all deviation-related documentation is accurate, up-to-date, and compliant with regulatory requirements and internal procedures.
• Collaboration and Communication:
  • Lead regular meetings to discuss deviation investigations, progress, and outcomes with cross-functional teams.
  • Provide guidance and support to departments in the drafting and management of deviations.
• Continuous Improvement:
  • Analyze deviation data to identify recurring issues and propose improvements to processes and procedures.
  • Develop and implement strategies to reduce deviation rates and enhance overall quality management.

Qualifications:

• Bachelors degree in a relevant field such as Life Sciences, Chemistry, or Engineering. Advanced degrees or certifications (e.g., Six Sigma, Root Cause Analysis) are a plus.

• Minimum of 8 years of experience in deviation management or a related role within the pharmaceutical industry.
• Proven experience in conducting root cause analyses, managing documentation, and leading investigations.
• Strong understanding of deviation management processes, quality systems, and regulatory requirements.
• Effective communication and interpersonal skills, with the ability to lead meetings and collaborate with cross-functional teams.
• Proficiency in relevant software and tools for documentation and metrics compilation.