Biotechnology QA Senior Associate

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.

Role of this position

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.

JOB 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.

Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.