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Clinical QA Audit Specialist, Sant Cugat del Valles



Grifols Shared Services North America, Inc


Sant Cugat del Valles, Spain 

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Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries. We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise. **WHO WE ARE** Grifols is a global healthcare company with more than 75 years of history improving the health and well-being of people around the world. We produce essential plasma medicines for patients and provide hospitals, pharmacies, and healthcare professionals with tools, information, and services they need to efficiently deliver expert medical care. We are present in more than 100 countries, with global headquarters in Barcelona, Spain, where the company was founded. As a company committed to serving people, we seek to hire and retain the very best employees. Our day-today corporate culture reflects the Grifols Spirit, which is defined by our Values. From **Clinical Quality Assurance department** we are looking for a **Clinical QA Audit Specialist** . **YOUR TASK AND RESPONSABILITIES** Conduct audits according to plan in support of Clinical programs. Work with Clinical Staff to resolve audit findings and offer suggestions for improvement. Serve as a resource for Clinical staff regarding issues of compliance within area of expertise. Communicate issues to department management. **Primary Responsibilities for role:** + Plan and conduct in-depth audits of CROs, vendors, clinical trial sites, and documentation associated with clinical trials. Assess compliance with applicable regulations and standards. + Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policy, and regulations/standards. + Prepare audit reports and discuss findings with auditees and internal customers. Track and follow up on the resolution of audit findings. + Assist in the conduct of GXP audits as assigned. + Provide guidance to Clinical staff in resolving audit findings in a compliant manner. + Assist internal groups in preparing for inspections by regulatory agencies and participate in on site regulatory inspections as appropriate. + Requires travel to CRO, vendor, and/or clinical trial sites + Management CAPAS related with issues detected in the audits. + Good knowledge of regulatory requirements and guidances including GCP, GCLP, GLP, and/or medical device areas. Has experience in interpretation and implementation of these regulations and guidances in Clinical QA. Excellent written and oral communication skills. Good interpersonal relations and influence skills. Ability to define risk as it relates to specific non-conformances or trends and work with clients to mitigate identified risks. **WHO YOU ARE** + Life Sciences Master and Degree. + A minimum of 5 years in a similar role. + Native level of Spanish and Advanced in English **WHAT WE OFFER** It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Information about Grifols is available at www.grifols.com at http://www.grifols.com/ It you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply! We look forward to receiving your application! Grifols is an equal opportunity employer. **Contract of Employment:** Permanent position **Location: SPAIN : España : Sant Cugat del Vallès**
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