Senior Quality Assurance Associate

2 weeks ago

Limerick, Ireland BARDEN Full time
Senior Quality Assurance Associate – Biotechnology Operations

Barden are delighted to be supporting our Global Biopharmaceutical client in their search for a Senior Quality Assurance Associate – Biotechnology Operations for their state-of-the-art start up biotech manufacturing campus in Limerick.

ABOUT THE ROLE:

The Senior Quality Assurance Associate – Biotechnology Operations will play a critical role in maintaining the quality and regulatory compliance of their biopharmaceutical products within their next-generation manufacturing facility. You will also work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.

  • 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.
  • 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.
  • 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.
  • Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
  • Participate in risk assessments and quality improvement projects.
  • Provide training to staff on quality-related procedures and best practices.
  • Stay informed about the latest developments in biotechnology and quality assurance.

ABOUT THE PERSON:

Education & Work Experience:

  • 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.
  • Excellent problem-solving and analytical skills.
  • Detail-oriented with a strong commitment to maintaining high-quality standards.
  • Effective communication and teamwork skills.
  • Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.
  • Experience with quality management systems (e.g., TrackWise, MES) is a plus.

Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.

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