Senior QA Associate - Operations
Life Science Recruitment
- Limerick
- Permanent
- Full-time
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.
- 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.
- 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.