Quality Assurance Auditor - Clinical Labs at PPD

Job description

The QA Auditor - GCLP (Good Clinical Laboratory Practice) For Clinical Labs Will Conduct Internal And/or External Audits And Inspections To Ensure Compliance With Established Quality Assurance Processes, Standards, Global Regulatory Guidelines And/or Client Contractual Obligations, Identify And Address Non-conformance Issues, Plan And Deliver Quality Services For Contracted Quality Assurance Audits, Internal Site Audits, Laboratory Audits And File Audits For Clients And Projects, Apply Company Policies And Procedures To Resolve Routine Issues As Well As

• Prepare, schedule, perform GCLP audit of clinical laboratories
• Present audit observations to internal project team
• Keep management (Audit Team Management) informed of potential compliance risks identified during audits
• Submit audit report for QC and respond to comments/queries
• Assist in the overall coordination of the laboratory audit report review functions
• Mentor new team members
• May conduct accompanied field visits
• May prepare, develop GCLP course materials and deliver GCLP training
• May back-up and support for the Audit Team Manager
• May also have frequent interaction with client representatives and other internal key stakeholders within PPD which are to be performed with tact, diplomacy and based on knowledge, facts and experience.

Education And Experience

• Bachelor's degree in Medical Technology or equivalent
• 1 to 5 plus years of previous QA experience highly preferred
• 1 to 4 years of Medical Technology bench experience required in a certified laboratory setting
• Valid annual licensure with the HPCSA (South Africa)

Knowledge, Skills And Abilities

• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology) along with good interpersonal skills
• Superb knowledge of Laboratory Quality Systems
• Very good problem solving, risk assessment and impact analysis abilities
• Basic computer skills in Microsoft Word, Excel and PowerPoint
• Flexible and able to multi-task and prioritize competing demands/work load
• Valid driver's license and passport

Please note we are currently candidate pooling for these positions, and candidates will be contacted as and when positions become available. The roles are full time & permanent positions, and can be home or office based in South Africa.

Preference will be given to employees from the designated groups in line with the provisions of the Employment Act No.55 or 1998 (and any amendments thereto), PPD’s recruitment policy and the Employment Equity Plan.

Organization

Global Quality and Compliance

Primary Location

Europe, Middle East & Africa-South Africa

Other Locations

Europe, Middle East & Africa-SA-Gauteng, Europe, Middle East & Africa-SA-Gauteng-Bryanston, Europe, Middle East & Africa-SA-Gauteng-Bryanston - Home Based, Europe, Middle East & Africa-SA-Gauteng-Johannesburg, Europe, Middle East & Africa-SA-Gauteng-Johannesburg - Home Based
Seniority Level

Not Applicable
Industry

Biotechnology Pharmaceuticals Research

Employment Type

Full-time
Job Functions

O