QA Auditor / Associate Manager

Important Information

Position

QA Auditor / Associate Manager (office based)

Location

Centurion,
Gauteng

Application Closing Date

20 March 2020

Job Specification

Introduction

  • We are a clinical research Solutions Organization, based in Pretoria, for global biopharmaceutical sponsors to optimize drug development. We have a full service clinical central laboratory with a broad range of capabilities.

Main job purpose

  • Plan, conduct, and report assigned quality assurance audits. Support management in promotion and assessment of compliance to regulations, guidelines and policies. Provide quality assurance oversight under the direction of Exec Director/delegate through interaction with customers, project and study teams and associated Cytespace functions.

Main Objective

  • Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Cytespace Africa Laboratories contract to assess compliance with applicable regulations/guidelines, customer requirements, Cytespace Africa SOPs and project-specific guidelines/instructions.
  • Conduct quality assurance activities and projects for clients according to Cytespace Africa departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits.
  • Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed.
  • Support hosting of customer audits as directed by line management.
  • Assist in preparation and review of corrective action plans associated with customer, internal and vendor audits
  • Document and report quality and compliance issues to management according to required timelines.
  • Advise management on system and vendor audit needs.
  • Provide oversight to the ISO 15189 accreditation program
  • Enhance and maintain a working knowledge of relevant GCP regulations

Critical Job Requirements

Qualification(s) and Experience

  • Bachelor’s/primary degree
  • 3 years’ experience in a laboratory, pharmaceutical, technical, or related area including GCP and/or Quality Assurance experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience

 Knowledge

  • Knowledge in relation to the laboratory environment and specifically ISO 15189 requirements and application
  • Considerable knowledge of GCP regulations and quality assurance auditing techniques.
  • Knowledge of word-processing, spreadsheet, and database applications.
  • Strong interpersonal skills.
  • Excellent problem-solving skills.
  • Effective organization, communication, and team orientation skills.
  • Ability to initiate assigned tasks and to work independently.
  • Ability to manage multiple projects.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients

 Package and Remuneration

  • Salary: Market Related

Location

125 Amkor Road, Lyttelton Manor, Centurion, Gauteng, 0157

Email Us

info@cytespacelabs.com