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Senior Quality Specialist

5 months ago

Runcorn, United Kingdom CK Group Full time

**Salary**:£21.03ph PAYE
- **REF Number**:00055210
- **Consultant**:Lucy Pinnick
- **Contact**:01246 457725
- **Date Published**:06.03.2023
- **Sector**:Pharmaceutical
- **Location**:Runcorn, North West
- **Discipline**:Quality

CK Group are recruiting for an Senior Quality Specialist to join a global pharmaceutical company, based in Runcorn on a contract basis initially for 12 months. A mix of office and homeworking will be accommodated in this role.

**Salary**: Per Hour £21.03 PAYE

Company: Our clients aim is to be a global leader in generics and biopharmaceuticals, improving the lives of patients across the world.

Location: Runcorn This site specialises in difficult-to-make medicines which means the site isteeming with bright and ambitious professionals who are passionate about what they do. This site develops a range of sterile liquid products mainly for use in the treatment of respiratory conditions and also MS, for markets around the world.

Senior Quality Specialist Role:

- Provide guidance & support to the Quality function ensuring designated Quality Systems are operated in compliance with Regulatory and Company standards.
- Generate, issue & control CGMP documentation to support existing Quality Systems and processes.
- Act as Lead auditor, to identify, action and close out all non-compliance issues.
- Design & deliver CGMP & Quality Systems training in line with Site requirements.

Your Background:

- Full understanding of CGMP.
- Knowledge of Quality Systems / documentation.
- Knowledge of QMS Processes such as Change Control, Deviation, CAPA etc.
- Knowledge of Pharmaceutical GMP regulations (EU & USA)