QA Manager - London/Chelsea

Recruiter
St Stephen’s Clinical Research Ltd
Location
Essex
Posted
25 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
As a Quality Assurance Manager you will head the Quality Department with the support of a QA Administrator. Reporting to the Associate Director you will act alongside other members of the Senior Management Team to assure further growth of the business. This is a diverse and expanding role, requiring ability to build excellent relationships but also act entirely independently, embrace and successfully deliver change, resolve organisational issues and demonstrate strong ethical standing Specific duties and responsibilities of the role include, but are not limited to: Maintenance of Quality Management System: Generation, review, management and facilitation of access to the controlled documents. Maintenance of an independent audit schedule. Audit scheduling, planing, conduct, reporting and followed up Maintenance of CAPA system Maintenance of Vendor Management System Computerised System Validation support and Implementation activities Inspection readiness and management of inspection/audit hosting activities Provision of GCP and/or QMS related training needs Advice on GCP Compliance, Regulations and Guidelines Management of non-compliance investigations Leading communication across the organisation on GCP and Quality: Manage internal quality meetings Provide broader compliance awareness & information Nurture a culture of quality and compliance Act as a member of the Senior Management Team to foster a culture of excellence and quality across the organisation. Experience required: Life Sciences degree or equivalent hands on experience Excellent knowledge of GCP & appropriate regional clinical trial regulations and guidelines At least 2-3 years experience in quality assurance and auditing in a GCP environment. Experience of authoring and developing SOPs and related documents GVP, GDP or GMP experience is also desirable Experience across both commercial and non-commercial clinical research is advantageous Excellent communication and organisational skills, and a flexible approach Location: London/Chelsea Salary: £45-50k (dependent upon experience)

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