SUMMARY:
Senior Validation Officer
POSITION INFO:
SENIOR VALIDATION OFFICER
Minimum Requirements
• Bachelor’s degree or National Diploma in Chemical engineering or Process engineering, Biotechnology, Microbiology, Chemistry, or relevant science or engineering qualification.
• Five (5) years’ experience in a pharmaceutical manufacturing environment.
• Three (3) years’ experience in validation of equipment, manufacturing processes, cleaning procedures, utilities and analytical methods.
• Two (2) years’ supervisory experience.
Specific Operational Requirements
• The successful candidate will be required to work an 8 hour day between 06h00 to 18h00 as rostered.
• The successful candidate may be required to work overtime to meet the business needs.
• The successful candidate must be prepared to work shifts when needed to support the company’s validation activity requirements.
• Must have own transport.
Key Performance Areas
• Oversee and drive validation team day-to-day tasks and activities
• Lead validation plan execution
• Compile validation documentation
• Compile validation reports
• Compile validation quality plans
• Management of the requalification programme
• Facilitate technical and non-technical training
• Facilitate impact and risk assessments for qualifications
• Sample management related to validation
• Provide support to Validation Manager and internal customers regarding validation requirements, problem solving, investigations and reporting.
• Adhoc activities related to validation and quality projects
Competencies
• Good working knowledge of the technical concepts required for validation in a cGMP environment
• Hands on experience with validation of equipment, processes, analytical methods, computerised systems and cleaning protocols
• Good team leader and team player
• Effective interpersonal skills and emotional intelligence
• Excellent attention to detail
• Quality orientation and awareness
• Excellent planning and organising skills
• Strong analytical and problem solving skills
• Ability to work independently with minimal supervision
• Excellent technical writing skills is required
• Ability to handle typical team conflicts
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