Quality Assurance Auditor GCP

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De opdrachtgever

Biopharmaceutisch bedrijf in de provincie Groningen

De omschrijving

As our new QA Auditor you will assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to. internal process audits, study specific audits (e.g. internal and external investigator site, in process, trial master file, clinical study reports) and audits of vendors used to support the companies services.

The QA auditor provides consultation, mentoring and compliance for the organization on GCP areas by ensuring quality activities are performed and documented in compliance with Standard Operating Procedures (SOPs), company guidelines, and applicable regulations. Besides this the QA Auditor:

• Performs contracted, routine and complex audits according to client expectations and/or SOPs.
• Plans and ensures audits are scheduled.
• Conducts audits to identify non-conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness.
• Reports observations/findings according to client or PRA SOPs and report templates.
• Tracks, collects and reports responses and corrective actions per contract with client or the companies SOPs.
• Documents closure of audit
• Shares questions and issues posed to QA with global the companies QA staff as necessary to insure best advice is obtained.
• Facilitates client audits and regulatory inspections to ensure that client auditors and inspectors receive access to needed documentation and staff with minimal disruption of ongoing operations.
• Assigned to participate in QA projects such as management of issue escalations, CAPA projects, or other QA initiatives.

De eisen

• Life science degree on Bachelor or Master level from an accredited institution
• Read, write and speak fluent English, conversational in Dutch.
• 2+ years experience working the clinical, regulatory, or quality environment within CRO/ pharmaceutical / healthcare environment.
• Work experience in early phase clinical trials or drug safety is considered an additional benefit.
• Excellent verbal and written communication skills, interpersonal skills.
• Experience in Quality Assurance function is strongly preferred.

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