Manager of Quality Control Systems

2 days ago


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

We're a dynamic and innovative organization that values diversity and inclusion. As Director of Regulatory Compliance, you'll be responsible for ensuring all products and processes comply with relevant regulations and guidelines.

You'll lead internal audits and participate in external audits and regulatory inspections. You'll also develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.

Key Responsibilities:

Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.

  • Oversee the management of SOPs, Work Instructions, and other quality-related documentation.
  • Collaborate with the Qualified Person (QP) to ensure batch documentation is reviewed, and products are released in compliance with regulatory requirements and company standards.

Audits and Inspections:

  • Lead internal audits and participate in external audits and regulatory inspections.
  • Prepare audit reports, manage corrective and preventive actions (CAPAs), and follow up on audit findings.

Training and Development:

  • Develop and execute training programs for staff on quality-related topics to ensure compliance with regulatory requirements and company standards.
  • Monitor the effectiveness of training programs and maintain training records.

Required Qualifications:

  • Bachelor's degree or higher in Pharmacy, Chemistry, Biology, or a related field.
  • A minimum of 5 years of experience in quality management within the pharmaceutical industry.
  • In-depth knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.
  • Experience with QMS implementation and management.


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