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Details
Senior QA Associate - Operations
Reference: | SCAKYX-607271 | Location: |
Limerick Limerick City |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
QA Specialist, QA Supervisor
Sr. Associate - Quality - Biotechnology Operations
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.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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