Quality Qualified Person
Posted 1 day ago by CK Group
£100 Per hour
Outside
Undetermined
Runcorn, England, United Kingdom
Summary: The Quality Qualified Person will join a global pharmaceutical company on a 12-month contract, ensuring compliance with cGMP principles during manufacturing, packaging, and testing operations. This role involves verifying batch documentation, certifying batches, and ensuring compliance with various regulatory requirements. The ideal candidate will have significant experience in a senior Quality role within the pharmaceutical industry and be registered as a Qualified Person. The position is based in Runcorn, England.
Key Responsibilities:
- Ensure compliance with cGMP principles during manufacturing, packaging, and testing operations.
- Verify batch-related documentation for regulatory compliance.
- Review and certify batches according to business shipment schedules.
- Ensure compliance with Product Licences, ANDAs, Manufacturer's Licence, Technical Agreements, and CE Certification requirements.
- Support planned changes or deviations with appropriate sampling, inspection, testing, and checks.
Key Skills:
- Qualified to Degree level or equivalent in Science.
- Membership of an appropriate professional body.
- Registration as a Qualified Person with acceptability to the Licensing Authority.
- Significant experience in a senior Quality role within the pharmaceutical industry.
- Ability to work effectively with peers and partners to positively impact performance.
Salary (Rate): £100.00/hr
City: Runcorn
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: outside IR35
Seniority Level: Senior
Industry: Other
CK Group are recruiting for a Quality Qualified Person to join a to join a global pharmaceutical company on a contract basis for 12 months.
Salary: From £100 per hour PAYE depending upon experience
Quality Qualified Person role:
- To ensure the principles and guidelines of cGMP have been met during manufacturing, packaging and testing operations.
- To verify all batch related documentation is compliant with the requirements of the regulatory authorities.
- To review and certify batches in line with business shipment schedules.
- To ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer's Licence, Technical Agreements, CE Certification requirements have been met to ensure compliance.
- To ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and check to ensure compliance with the requirements of the regulatory authorities
Your Background :
- Qualified to Degree level or equivalent in Science.
- Membership of appropriate professional body.
- Registration as a Qualified Person, with acceptability to the Licensing Authority
- Significant experience in a senior Quality role with experience as a Quality Leader in a modern manufacturing environment within the pharmaceutical industry desirable.
- The ability to work effectively with peers, partners and others, to positively impact performance.
Company:
Our clients aim is to be a global leader in generics and biopharmaceuticals, improving the lives of patients across the world.
Location:
This role is based at our clients site in Runcorn.
Apply:
For more information, or to apply for this Quality Qualified Person role please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 164 188.
Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check. It is essential that applicants hold entitlement to work in the UK.