Hyper Recruitment Solutions are currently looking for an experienced QA Auditor to join a leading Pharmaceutical company based in the Cambridgeshire a... View Job
Qualified Person (Home Based)
We are currently looking for a Qualified Person to join a leading life sciences company based in the Buckinghamshire area. As the Qualified Person you... View Job
Head of Quality Assurance
We are currently looking for a Head of Quality Assurance to join a leading Pharmaceutical company based in the South East of the UK. As the Head of Qu... View Job
We are currently looking for a Quality Systems Manager to join a leading Biopharmaceutical company based in the Hertfordshire area. As the Quality Systems Manager you will be responsible for the Quality unit, driving operational and Quality System improvements, ensuring regulatory, internal and GMP regulations.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Systems Manager will be varied however the key duties and responsibilities are as follows:
1. You will be the primary contact for Quality, defining, leading and managing our clients appropriately formed Quality team. In doing so you will take responsibility for site Quality Systems, whilst also being the primary contact for inspections by regulatory agencies.
2. As the Quality Systems Manger, you will conduct System specific projects and System Audits, assessing the quality standards and provide recommendations for changes and improvements. You will also help prepare audit reports, identifying challenges or failures to meet standards, and will drive improvement projects ensuring resolutions.
3. You will command the ongoing continuous improvement of all Quality processes throughout the site, using operational excellence tools to resolve operational and system issues, helping to raise a Quality culture throughout.
4. During Leadership management meetings, you will provide regular feedback about Quality standards on site, providing feedback and recommendations for their improvement. You will will ensure the business is fully aware of any regulatory changes and how this will impact the business.
To be successful in your application to this exciting opportunity as the Quality Systems Manager we are looking to identify the following on your profile and past history:
1. Previous experience handling inspections by Regulatory Authorities. Previous experience with the MHRA is essential and experience working with FDA would be advantageous
2. Proven industry experience, managing GMP Quality Assurance and Quality System teams. In-depth knowledge of GMP guidelines is essential and experience managing teams within Biologics manufacturing would be advantageous.
3. A working knowledge and practical experience of GCP principles and the regulatory requirements.
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.