Description:
A Biotechnology QA Senior Associate is required on a PERMANENT basis by CareerWise Recruitment for our Limerick based start-up Biopharmaceutical Client.
As a Biotechnology QA Senior Associate, you will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within client 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.
THE ROLE:
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 CoAs.
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.