Introduction •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. Job Functions Analysis,Compliance & Regulatory Affairs,Data Analysis,Investigation & Compliance,Monitoring & Evaluation,Quality Control,Risk Analysis Industries Chemical / Petrochemical,Fmcg (Fast Moving Consumer Goods Sector),Food & Beverages,Manufacturing,Oil & Gas,Pharmaceutical / Medical / Healthcare / Hygiene,Technical Specification •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 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 •Know•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 ledge of Analytical, technical and Engineering methods •Attention to detail; Time Management •Planning skills; Problem solving •Organizational skills; communication Skills •Protocol and technical report writing skills and Computer literacy