Job Reference: J5631707
Updated On: 23/03/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Quality Assurance Specialist to join a leading life science company based in the Hertfordshire area. As the Quality Assurance Specialist you will be responsible for the continuous development and maintenance of the site wide QMS, whilst also ensuring compliance with GMP standards with third parties.
Key Duties and ResponsibilitiesYour duties as the Quality Assurance Specialist will be varied however the key duties and responsibilities are as follows:
1. You will be tasked with the development and maintenance of the site wide Quality System, ensuring that products are manufactured within GMP regulations.
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 RequirementsTo 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
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