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Validation Officer (12 months contract)

Employer: Fresenius Kabi Manufacturing SA Ndawoni: Port Elizabeth Province: Eastern Cape

Unjani: Contract Ngowantoni: Engineering

Fresenius Kabi Manufacturing SA Validation Officer (12 months contract) Port Elizabeth

Purpose

  • To prepare, plan, co-ordinate, execute all site validation activities
  • To ensure the Validation Department for FKMSA Port Elizabeth facility complies with SAHPRA/cGMP/PICS and corporate guidelines.

Requirements

  • A Life Science or Engineering degree or equivalent. 
  • 3-5 years of experience of validation in the pharmaceutical industry
  • Knowledge of production processes
  • Systems, product, industry and equipment knowledge
  • Use of statistical techniques 
  • Knowledge of Analytical, technical and Engineering methods.

Responsibilities

  • Development of User Requirement Specifications
  • Development of Manufacturing Procedures
  • Qualification and re-qualification of equipment and utilities
  • Development and execution of System Impact Assessments and Component Impact Assessments
  • Development and execution of Validation Risk Assessments and Design Reviews
  • Development and execution of Design Qualifications, Installation Qualifications, Operational Qualifications and Performance Qualifications taking a System Lifecycle Approach
  • Development and execution of Process Validation studies
  • Validation of computerised systems validation
  • Validation of Automated System
  • Validation of sterilisation equipment and cycles
  • Performance of Factory Acceptance Testing and Site Acceptance Testing
  • Control of delegated Validation Plans.
Lomsebenzi ufakwe ngu Siseko Gwegwe nge 19 ka May 2020