Thermo Fisher Scientific QA GCLP Auditor Jobs in Kenya

Thermo Fisher Scientific QA GCLP Auditor Jobs in Kenya

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies, and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

About the role

The GCLP Quality Auditor assess medical laboratory activities to assure that GCLP and contractual obligations to client companies are met and determines whether clinical trial laboratory testing is conducted and reported in accordance with GCLP Guidelines, regulatory requirements, and relevant PPD and client procedural documents.

Performs routine GCLP audits. Work assignments include multiple therapeutic indications across different projects and clients.

Conducts a variety of client, internal, or GxP audits and supports regulatory inspections as requested by senior management

Participates in process audits

Performs other types of QA audits or activities (e.g., database audits, clinical study report audits, sample results tables, facility audits, process improvement)

Serves as a resource to operational departments on audit or quality assurance subject matter

Prepares and presents audit findings and/or other related information at departmental,

internal operations or client meetings.

Education and Experience

Bachelor’s degree in Medical Technology, or other related laboratory sciences. ASCP certification is an added advantage

2 - 3 years of Experience in Quality or compliance environment in a medical laboratory or pharmaceutical company and a previous experience in audit activities is an asset as well as the knowledge of the GCLP guidelines from DAIDS, BARQA and/or EMA/INS/GCP/532137/2010

Experience in microbiology, hematology, and clinical chemistry

Experience in GLP useful with a preference for GCLP, and/or CLIA.

Working knowledge of Quality Assurance, GCLPs, or CLIA.

10 years’ experience with clinical laboratory operations, deliverables, and services (Laboratory Equipment/Instrumentation, Testing Facility Operations, Laboratory Information Systems, Laboratory Safety, Quality Management Systems, Records and Reports, Specimen Management and Tracking and Verification of Performance Specifications)

Strong verbal and written skills in English. Individual with additional language skills in Thai/ Vietnamese will be highly considered.
Great organizational skills

Must be willing to travel internationally (post-pandemic) at 50-70% capacity. Local travel is expected during the pandemic.

How to Apply

For more information and job application details, see; Thermo Fisher Scientific QA GCLP Auditor Jobs in Kenya

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