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Quality Assurance Specialist

£45,000 - £53,000 per annum
Job Reference: J5633549
Updated On: 24/07/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: MHRA QP License Holder, Cell & Gene Therapy

Skills: Quality Assurance - Permanent, Quality Assurance - GMP, Quality Assurance - Compliance, Quality Assurance - Quality Manager, Quality Assurance - Biologics, Quality Assurance - ATMPs

Job Information

Role Overview

We are currently looking for a Quality Assurance Specialist to join a leading life science company based in the Stevenage area. As the Quality Assurance Specialist you will be responsible for establishing and maintaining the site QMS to GMP regulations.

Key Duties and Responsibilities

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

1. You will work with multiple teams to help design, implement and maintain the QMS for the new site ensuring GMP compliance for the businesses new manufacturing facility.

2. You will act as a Quality Assurance subject matter expertise for the facilities operations, including participating in regulatory and customer audits and visits. You will also promote awareness of Quality Assurance and GMP guidelines, driving a Quality culture throughout the site.

3. As the Quality Assurance specialist, you will support staff with training and compliance, CAPAs, GMP Documentation, Change Controls and incidents.

4. You will maintain processes and SOPs, including GMP document control and training, ensuring the site is always compliant.

Role Requirements

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

1. Previous experience in establishing a QMS to GMP standards is essential for this position.

2. Proven experience working with regulatory bodies, such as MHRA, FDA hosting/participating in audits.

3. A working knowledge and practical experience working within a life science / pharmaceutical GMP environment.

Key Words: QA | Quality Assurance | Quality | GMP | Audit | MHRA | FDA | Pharma | Bio | CAPA | Documentation | QMS | Quality Systems | Senior | R&D | Manufacturing | Good Manufacturing Practice
Chris Carey
Your Recruitment ConsultantChris
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We 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 recruitment processionals and scientists. We look forward to helping you with your next career moves.