QA GCLP Auditor I/II job at PPD
Website :
722 Days Ago
Linkedid Twitter Share on facebook

Vacancy title:
QA GCLP Auditor I/II

[ Type: FULL TIME , Industry: Health Care , Category: Accounting ]

Jobs at:

PPD

Deadline of this Job:
15 December 2022  

Duty Station:
Within Kenya , Nairobi , East Africa

Summary
Date Posted: Thursday, December 01, 2022 , Base Salary: Not Disclosed

Similar Jobs in Kenya
Learn more about PPD
PPD jobs in Kenya

JOB DETAILS:
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.

Job Qualification
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.


Work Hours: 8


Experience in Months: 24

Level of Education:
Bachelor Degree

Job application procedure

Interested and qualified? Go to PPD on careers.ppdi.com to apply


All Jobs

QUICK ALERT SUBSCRIPTION

Job Info
Job Category: Accounting/ Finance jobs in Kenya
Job Type: Full-time
Deadline of this Job: 15 December 2022
Duty Station: Nairobi
Posted: 01-12-2022
No of Jobs: 1
Start Publishing: 01-12-2022
Stop Publishing (Put date of 2030): 01-12-2065
Apply Now
Notification Board

Join a Focused Community on job search to uncover both advertised and non-advertised jobs that you may not be aware of. A jobs WhatsApp Group Community can ensure that you know the opportunities happening around you and a jobs Facebook Group Community provides an opportunity to discuss with employers who need to fill urgent position. Click the links to join. You can view previously sent Email Alerts here incase you missed them and Subscribe so that you never miss out.

Caution: Never Pay Money in a Recruitment Process.

Some smart scams can trick you into paying for Psychometric Tests.