Job Title: Biotechnology Quality Assurance (QA) Senior Associate 

Location: County Limerick, Ireland 

Company Overview: 

Our client, a leader in biopharmaceutical innovation, is seeking a talented Biotechnology Quality Assurance (QA) Senior Associate to join their state-of-the-art manufacturing facility. This role offers a unique opportunity to be part of a forward-thinking organisation that is at the forefront of developing next-generation biopharmaceutical products. If you are passionate about maintaining the highest standards of quality and regulatory compliance, this role is an ideal match for your expertise. 

Role Overview: 

As a Biotechnology QA Senior Associate, you will play a pivotal role in ensuring that our client's biopharmaceutical products meet stringent quality and regulatory standards. You will work closely with cross-functional teams to implement quality assurance protocols, oversee compliance with current Good Manufacturing Practices (cGMP), and support continuous improvement initiatives within the facility. 

Key Responsibilities: 

Quality Assurance Oversight: 

• Policy Development: Develop and maintain robust quality assurance procedures, policies, and systems. 

• Compliance Monitoring: Conduct routine self-inspections and time-on-the-floor assessments to ensure strict adherence to cGMP and relevant regulations. 

• Collaboration: Partner with production and quality control teams to ensure consistent product quality throughout the manufacturing process. 

• Issue Resolution: Investigate and resolve deviations, non-conformities, and implement Corrective and Preventive Actions (CAPA) to safeguard product integrity. 

Regulatory Compliance: 

• Regulation Updates: Stay informed of the latest industry regulations, guidelines, and best practices. 

• Audit Support: Assist in the preparation and execution of regulatory inspections and audits. 

• Regulatory Assurance: Ensure all products meet regulatory requirements, with comprehensive documentation and reporting. 

Documentation and Reporting: 

• Record Maintenance: Maintain precise and comprehensive quality records, including batch records, change control documentation, and quality reports. 

• Documentation Review: Prepare and review critical documentation related to product quality and compliance, including GMP standard operating procedures, process flow documents, and equipment qualification. 

• Batch Disposition: Perform batch disposition duties, including the approval of drug substance batch records and associated Certificates of Analysis (CoA). 

Quality Improvement Initiatives: 

• Process Enhancement: Identify areas for process improvement and collaborate with cross-functional teams to implement effective changes. 

• Risk Assessment: Participate in risk assessments and quality improvement projects to drive continuous enhancement of quality standards. 

Training and Development: 

• Staff Training: Provide comprehensive training to staff on quality-related procedures and industry best practices. 

• Continuous Learning: Stay updated on the latest developments in biotechnology and quality assurance. 

Qualifications: 

• Educational Background: BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or a related discipline. 

• Experience: 5+ years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment. 

• Expertise: Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other relevant biopharmaceutical regulatory requirements. 

• Skills: Excellent problem-solving, analytical skills, and a meticulous approach to maintaining high-quality standards. 

 

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

For further information on this role please contact Lisa Lawlor on 086 839 5533 or email stem@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. 

 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”