Senior Quality Assurance Auditor

What will you be doing?

As a Senior Quality Assurance Auditor you will conduct and manage quality, compliance, and auditing activities to provide assurances that  operational activities are conducted in compliance with applicable regulations, guidelines and the company’s policies and standards.

As a member of a global vibrant and passionate auditing department, you will perform a variety of audit activities such as: vendor audits/vendor qualification activities, study specific audits (e.g.  investigator site,  trial master file, study report), internal process audits, pharmacovigilance system audits, and contracted audits.  

You will also assist with facilitation of sponsor audits and, as required by the management team, in preparations for and participate in regulatory authority inspections.

You will typically be the primary contact for any local audit activities that are required to be performed.

In addition, with your strong knowledge of GCP, along with other GxPs as applicable, and your understanding of regulatory expectations, you will provide consultation and compliance advice for the organization and support a quality framework that protects patient safety and assures regulatory compliance. This includes interpretation of regulations and guidelines, searches of published information and interactions with other QA and regulatory professionals.

You will have the opportunity to bring your expertise in international regulations and guidelines to support compliance projects such as management of quality issues, CAPA projects, or other Quality Assurance and cross-functional initiatives.

Location: UK remote or office-based

What do you need to have?

• Experience in a Quality Assurance function / GxP quality assurance auditing in Clinical Research/ Pharma/CRO
• 5+ years  overall experience in working  in the clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare environment
• Robust experience in GCP; additional experience in other GxP areas, preferred  (e.g. GLP, GVP, GMP, GDP )
• Vendor audit experience in a variety of vendor types is highly preferred
• Computer Systems Validation (CSV) experience, preferred
• Excellent verbal and written communication skills
• Excellent interpersonal skills,
• Excellent organizational skills
• Read, write and speak fluent English
• An undergraduate degree, its international equivalent in health sciences, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required

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