Job Summary
We are seeking a highly skilled Quality Operations and Product Disposition Specialist to join our team. In this role, you will play an active part in ensuring the quality of our products and processes.
The successful candidate will have a strong background in quality assurance, with a focus on batch review and certification, quality management systems, and regulatory compliance.
Key Responsibilities
* Review and approval of batch records for Cell Culture operations and Purification operations to ensure compliance with current Good Manufacturing Practices (cGMP) and batch review and batch disposition process.
* Participation in QA documentation management, resolution of documentation issues, and production of relevant metrics to monitor efficiency.
* Support change management, deviations, and corrective and preventative action (CAPA) systems as required.
* Support ongoing review of events, deviations, and non-conformances associated with batch release activities.
* Support site risk management procedures.
* Support ongoing running and maintenance of Electronic Quality Management System.
Required Skills and Qualifications
Literacy:
* Bachelor's degree in Life Sciences or related field.
* At least 5 years of experience in Biotech/Pharmaceutical QA, with a strong knowledge of cGMP guidelines.
Technical Skills:
* Excellent interpersonal and communication skills.
* Meticulous attention to detail.
* Self-motivation.
* Computer literacy.
* Strong time management awareness.
Benefits
We offer a competitive salary, bonus scheme, 25.5 days holiday per annum, defined contributory pension plan, private medical insurance, and flexible working arrangements.
Legal Statement
This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent.