Quality Assurance Officer

at  Charles River Laboratories

Req ID: 222334
Location:Keele, GB, ST5 5SP
At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.
As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

JOB SUMMARY

We are currently looking to recruit a Operational Quality Assurance Officer to work in the Quality Assurance department at our Keele facility. The ideal candidate will have experience working within a GMP Grade C cleanroom environment.
As part of the role you will need to have excellent attention to detail, have a pro active approach to problem solving, be able to effectively communicate, both verbally and in writing. The role will require you to be able to manage priorities whilst working both as part of a team and independently in a fast paced environment.

PROFILE AND REQUIREMENTS

The main duties will include:

• Provide ‘in suite’ operational QA oversight and assistance on quality related issues within the GMP manufacturing Grade D and Grade C Facility.
• Provide Facility Systems support, including review and approval of HVAC Pressures, Temperature, and Cleaning Logs,
• Perform ‘in suite’ Room Inspections and Release.
• Issue, review and approval of GMP batch manufacturing records to support QP certification and release.
• Assist in performance of internal self-inspection audits
• Generation, review and approval of relevant quality documentation
• Support with assessment of deviation event investigations
• Support closure to plan of Change Controls and CAPA actions.
• Assist and lead continuous improvement projects
• Review and approval of Validation reports.
• Archiving of operational and quality control documentation

Education / Experience:
Ideally Science degree or equivalent, with proven relevant experience in a pharmaceutical Manufacturing or Quality Assurance role.
Minimum requirement science related A level with 2 years experience in an operational Quality Assurance role. You will have good working knowledge of GMP, ideally in the pharmaceutical sector but this is not essential.
This role will be based at Keele, Staffordshire.

• Provide ‘in suite’ operational QA oversight and assistance on quality related issues within the GMP manufacturing Grade D and Grade C Facility.
• Provide Facility Systems support, including review and approval of HVAC Pressures, Temperature, and Cleaning Logs,
• Perform ‘in suite’ Room Inspections and Release.
• Issue, review and approval of GMP batch manufacturing records to support QP certification and release.
• Assist in performance of internal self-inspection audits
• Generation, review and approval of relevant quality documentation
• Support with assessment of deviation event investigations
• Support closure to plan of Change Controls and CAPA actions.
• Assist and lead continuous improvement projects
• Review and approval of Validation reports.
• Archiving of operational and quality control documentatio