- Bachelors 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 companies 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
- 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 are required
- Ability to handle typical team conflicts