Associate Specialist Quality Assurance

Location
Buckinghamshire
Salary
Competitive
Posted
27 Jan 2017
Closes
24 Feb 2017
Ref
J3487
Contact
Chris Sowden
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a Associate Specialist Quality Assurance to join a leading Biologic's manufacturing company based in the Buckinghamshire area. As the Associate Specialist Quality Assurance you will be responsible for maintaining GMP compliance across the manufacturing site.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Associate Specialist Quality Assurance will be varied however the key duties and responsibilities are as follows:

1. Review and approve SOP's ensuring they reflect accurate working practices, are logical and technically sound.

2. Take ownership of the Change Management system, raising and recording deviation for out of specification activity, deviations will be investigated and reports on them written. You will also raise CAPA's and assess change controls.

3. The Associate Specialist Quality Assurance will perform formulation and blend checks and monitor ampule stock levels, ensuring this is managed.

4. You will provide and drive septic training for production staff to continuously improve levels of sterility in the manufacturing environment.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Associate Specialist Quality Assurance Steriles we are looking to identify the following on your profile and past history:

1. Relevant degree in a Science discipline.

2. Proven industry experience in QA in a manufacturing environment, with Steriles experience.

3. A working knowledge and practical experience with GMP Quality Systems.

Key Words: Pharmaceuticals | GMP | cGMP | Quality Assurance | QA | Sterile | Licensed Medicines | Quality Management System | Change Control | CAPA's | Deviations | Supplier Management | Compliance | Audits | Specialist | Associate | Aseptic | Biologics | Quality

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.