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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior QA Associate - Operations


Reference:SCAKYX-607271 Location: Limerick
Limerick City
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist, QA Supervisor

Sr. Associate - Quality - Biotechnology Operations
Our client, a global biotech company, are seeking a highly motivated and detail-oriented Biotechnology QA Sr. Associates to join our quality assurance team and ensure the highest standards of product quality and compliance.

Key Responsibilities:
As a Biotechnology QA Sr. Associate, you will play a critical role in maintaining the quality and regulatory compliance of the biopharmaceutical products within the next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.

Quality Assurance Oversight:

  • Develop and maintain quality assurance procedures, policies, and systems.
  • Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
  • Collaborate with production and QC teams to ensure product quality throughout the manufacturing process.
  • Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality.
Regulatory Compliance:
  • Stay current with industry regulations, guidelines, and best practices.
  • Assist in the preparation and execution of regulatory inspections and audits.
  • Ensure that all products meet regulatory requirements, including documentation and reporting.
Documentation and Reporting:
  • Maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports.
  • Prepare and review documentation related to product quality and compliance including GMP standard operating procedures, process flow documents as well as equipment qualification and process validation documentation.
  • Perform batch disposition, including approval of drug substance batch records and associated CoA’s.
Quality Improvement Initiatives:
  • Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
  • Participate in risk assessments and quality improvement projects.
Training and Development:
  • Provide training to staff on quality-related procedures and best practices.
  • Stay informed about the latest developments in biotechnology and quality assurance.
Requirements:
  • BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
  • Minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
  • Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
  • Experience with quality management systems (e.g., TrackWise, MES) is a plus.
For more information, contact Sinéad on [email protected]/ +353879500821