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Quality Assurance Specialist

2 weeks ago

Limerick, Limerick, Ireland TN Ireland Full time

TN Ireland is a global healthcare organization dedicated to enhancing the quality of life through innovative medicines.

Job Description:

As a Senior Associate in Quality Assurance specializing in Manufacturing Execution Systems (MES), you will play a pivotal role in ensuring the quality and regulatory compliance of biopharmaceutical products within our advanced manufacturing environment.

You will collaborate closely with cross-functional teams to implement and uphold rigorous quality assurance standards, facilitate inspections and audits, and drive continuous improvement initiatives.

  1. Key Responsibilities:
  • Develop and maintain quality assurance procedures, policies, and systems.
  • Conduct routine self-inspections and monitoring assessments to ensure compliance with regulatory requirements.
  • Work collaboratively with automation, IT, and production teams to uphold quality standards throughout the manufacturing process.
  • Investigate and address deviations, non-conformities, and implement Corrective and Preventive Actions (CAPA) related to MES quality events.
  • Participate in cross-functional teams to ensure consistency across all manufacturing execution systems.
Regulatory Compliance:
  1. Stay abreast of industry regulations, guidelines, and best practices.
  2. Assist in preparing for and participating in regulatory inspections and audits.
  3. Ensure adherence to processes including periodic review, change control, deviation management, and security measures for MES.
Documentation and Reporting:
  1. Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
  2. Develop local procedures specific to MES and support the review and approval of GMP documents related to MES qualification and validation.
Quality Improvement Initiatives:
  1. Identify opportunities for process improvement and collaborate with cross-functional teams to implement enhancements.
  2. Participate in risk assessments and contribute to quality improvement projects.
Training and Development:
  1. Communicate GMP requirements and regulatory updates related to MES to personnel.
  2. Stay informed about advancements in electronic batch records (eBRs) and best practices in quality assurance.