- Generate & execute validation protocols and reports as required.
- Responsible for writing, executing & reporting of all validation activities including but not limited to (VP/ DQ / FAT / IQ / OQ / PQ / ARF’s / Deviations).
- Execution of validation studies including thermal qualification of equipment
- Process qualification including all areas of the validation life cycle.
- Responsible for planning and coordinating validation schedules on site and efficient execution of both short and long-term projects.
- Analyses the results of testing and determines the acceptability of results against pre-determined criteria.
- Responsible for all associated validation documentation compliant with GMP.
- Prioritize qualification activities in line with the project schedule.
- Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
- Resolve and assist in the closure of deviations initiated during qualification / validation execution.
- Generation, execution and close out of validation projects relating to new and existing equipment.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.
- Execution and documenting of process risk assessment / failure mode and effects analysis.
- Represent validation at internal and external audit.
- A minimum of 3 years’ experience in the Pharmaceutical Industry
- Strong communication and writing skills
- Good time management and planning skills
- Continuously drive to improve processes for improved performance
- Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint)
- Meets commitments on time
- Although not a requirement, experience of any of the following would be an advantage:
- Thermal Mapping of controlled temperature units.
- Laboratory equipment validation
- Sterilisation validation of autoclaves
- Commissioning, Qualification & Validation of new systems
- Utility qualification
For an immediate interview please forward your CV using the apply button
Or call Megan Warr on 091507515 for a confidential conversation