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Director of Quality Assurance

3 weeks ago

Dublin, Dublin City, Ireland West Pharmaceutical Services, Inc Full time

We are seeking a highly motivated and experienced individual to join our team as a Director of Quality Assurance in Dublin, Ireland.

About the Job:

The successful candidate will be responsible for overseeing the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.

Main Responsibilities:

  1. Quality Systems Management: Develop, implement, and maintain the QMS.
  2. Regulatory Compliance: Ensure that all products and processes comply with relevant regulations and guidelines.
  3. Audits and Inspections: Lead internal audits and participate in external audits and regulatory inspections.
  4. Training and Development: Develop and execute training programs for staff on quality-related topics to ensure compliance with regulatory requirements and company standards.
  5. Quality Control: Oversee the quality control processes, including raw material testing, in-process monitoring, and final product testing.
  6. Deviation and Change Control Management: Manage and investigate deviations, non-conformances, and product complaints.
  7. Product Release: Collaborate with the Qualified Person (QP) to ensure that batch documentation is reviewed, and products are released in compliance with regulatory requirements and company standards.
  8. Continuous Improvement: Promote a culture of continuous improvement by identifying areas for improvement and implementing effective solutions.

Requirements:

  1. Education: Bachelor's degree or higher in Pharmacy, Chemistry, Biology, or a related field.
  2. Experience: A minimum of 5 years of experience in quality management within the pharmaceutical industry.
  3. Skills and Competencies:
    1. Strong leadership and team management skills.
    2. Excellent communication and interpersonal skills.
    3. Attention to detail and strong analytical skills.
    4. Ability to handle multiple tasks and prioritize effectively.
    5. Proficiency in risk management and problem-solving.