Validation Co-ordinator – Temp Assignment 34 views

Job Overview

  • Salary Offer Market Related
  • Experience Level Senior
  • Total Years Experience 5-10

Purpose

Pharmaceutical manufacturer, providing a dynamic range of products and services is seeking a Validation Co-ordinator who will be responsible for performing equipment, processing and cleaning validations including existing as well as new equipment and minor changes to production process and equipment per ISO, PICS and SAHPRA requirements

Minimum Requirements

  • At least 5 years’ experience in Pharma Manufacturing or Sterile Filling experience is essential
  • On the job validation experience such as preparing and executing validation protocols
  • Continues improvement inclination experience
  • Exposure to local regulatory audits
  • Previous laboratory working experience will be an advantage
  • Scientific, Technical qualification in Chemistry, Chemical Engineering or equivalent
  • MS Office and MS Excel

Key Job Outputs:

  • Successful delivery of projects
  • Follow the organisation’s documentation practice
  • Conduct validations on process, equipment and cleaning
  • Gain in-depth technical understanding of processes and manufacturing
  • Conduct multi-disciplinary management of project teams
  • Conduct session facilitation and action planning
  • Conduct risk analysis and facilitate root cause analysis sessions
  • Perform process mapping exercises
  • Perform cleaning studies and hold time studies when required
  • Draw up and execute process validation schedule
  • Draw up and execute cleaning validation schedule
  • Proactively communicate with stakeholders internally and externally
  • Identify process improvement opportunities

Core Competencies:

  • Ability to understand engineering drawings
  • Methodical, structured and shows initiative
  • High level of accuracy and attention to detail
  • Problem-solving and decision-making skills
  • Able to work under pressure
  • Self-motivated team player
  • Uncompromising on quality
  • Strong time management skills
  • Ability to prioritise duties and responsibilities
  • Good Laboratory Practice and Good Manufacturing Practice
  • Strong interpretation and communication skills
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