QA Officer/Manager

London, London

In this role as a QA Officer, you will be responsible for the QA programme for our respected clients working within the life science sector. The successful candidate will manage, shape, and embed a quality culture within the organisation. The role of the QA Officer / Manager is to assure management that all the CRO and R&D research activities are performed in compliance with GLP and applicable GCP regulations, guidance, and expectations, and ensure a permanent state of inspection readiness. The QA Manager / Manager will assure the compliance of our client’s facilities, data integrity, staff training records, Standard Operation Procedures (SOPs), final study reports and foster the culture of quality throughout the organisation.

The role holder must have:

A Bachelor or above degree in Life Science or related subjects or equivalent quality-oriented education and training
Minimum 2 years work experience in Quality Assurance in a GLP environment, preferably in the Pharmaceutical CRO sector
An expert knowledge of GLP in pre-clinical toxicology, and GCP as it relates to clinical laboratories
A strong understanding of Computer Systems Validation in a GLP environment
Experience in hosting and participating in MHRA GLP inspections is desirable
The ability to promote regulatory awareness throughout the organisation
Strong analytical and training skills.
The ability to perform under pressure and know how to monitor progress
An excellent command of English, spoken and written
A strong team spirit and a mindset focused on quality and integrity

Responsibilities:

Lead and manage the audit program for GLP for Laboratories
Communicate the outcome of all quality assurance activities to the management team
Plan, design and perform inspections of the laboratory facility, systems and processes, and audit final reports for global GxP and SOP compliance
Manage CAPA systems to ensure all quality issues are corrected effectively
Develop robust Quality Assurance SOPs
Support the production of regulatory compliant policies and SOPs across the organisation
Manage the programme of quality oversight for external vendors
Ensure the organisation is always inspection and audit ready
Host and facilitate client and regulatory inspections
Keep abreast of changes to global regulations, guidance, and expectations
Provide staff training on current and new quality and compliance requirements
Maintain current knowledge of standard requirements according to GLP but can extended to GCP, GMP, CAP, ISO17025 and ISO 15189 guidelines related to the business process

Salary: £50,000 - £60,000 pa

Date Posted: 18/07/2022

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