Quality Specialist
Posted Today by Radiant Systems Inc
Negotiable
Undetermined
Undetermined
Runcorn, England, United Kingdom
Summary: The Quality Specialist role involves performing final QP Batch Certification to ensure that all products released to the market comply with various regulatory requirements. This includes verifying batch documentation, ensuring compliance with manufacturing and testing processes, and managing changes in production. The position requires strong communication skills and a commitment to high performance standards in quality and safety. A degree in science and significant experience in a senior quality role are essential for this position.
Key Responsibilities:
- Perform final QP Batch Certification to ensure compliance with regulatory requirements.
- Verify all batch documentation meets regulatory authority requirements.
- Review and certify batches according to business shipment schedules.
- Ensure compliance with Product Licences, ANDAs, Manufacturer's Licence, Technical Agreements, and CE certification.
- Support planned changes or deviations with appropriate sampling, inspection, testing, and checks.
- Notify planned or unplanned changes in manufacturing or quality control per established reporting systems.
- Ensure manufacturing and testing processes are validated and all necessary checks and tests are completed.
- Conduct appropriate audits, self-inspections, and spot checks by experienced staff.
Key Skills:
- Strong communication and teamwork skills.
- Ability to set and deliver high performance standards related to quality, safety, cost, and customer service.
- Degree-level qualification (or equivalent) in science.
- Membership of an appropriate professional body.
- Registered Qualified Person acceptable to the Licensing Authority.
- Significant experience in a senior Quality role.
- Experience as a Quality Leader in a modern pharmaceutical manufacturing environment is desirable.
Salary (Rate): undetermined
City: Runcorn
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
***QP Batch Certification is mandatory***
Purpose of Role
To perform final QP Batch Certification to ensure all products released to market comply with the requirements of the Manufacturer's Licence, Marketing Authorisations, ANDAs, Technical Agreements, CE certification, and relevant EU, USA, or other regulatory requirements (e.g. Russia, Brazil, Canada).
Key Result Areas
- Ensure cGMP principles and guidelines have been met during manufacturing, packaging and testing.
- Verify all batch documentation meets regulatory authority requirements.
- Review and certify batches according to business shipment schedules.
- Ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer's Licence, Technical Agreements and CE certification requirements are met.
- Ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and checks.
- Ensure planned or unplanned changes in manufacturing or quality control are notified per established reporting systems.
- Ensure manufacturing and testing processes are validated and all necessary checks and tests completed.
- Ensure appropriate audits, self-inspections and spot checks are carried out by experienced staff.
Areas of Impact Affecting the Job
Releasing non-compliant product can result in patient risk, recalls, investigations and possible prosecution of the QP and the Company. Appropriate measures must ensure processes, testing and products comply with licensed requirements.
Planning, Organising and Controlling
Release batches in line with business schedules where possible. Meet all requirements in the Key Result Areas, ensuring validation, checks and notifications are in place before release of any product.
Knowledge, Skills and Abilities
Skills
- Strong communication and teamwork.
- Ability to set and deliver high performance standards related to quality, safety, cost and customer service.
Core Competencies
Communication
Influencing
Qualifications and Accreditations
Degree-level qualification (or equivalent) in science. Membership of an appropriate professional body. Registered Qualified Person acceptable to the Licensing Authority. Significant experience in a senior Quality role; experience as a Quality Leader in a modern pharmaceutical manufacturing environment desirable.