Validation Project Manager

ICDS RECRUITMENT

MAYO

Validation Project Manager - County Mayo. Reporting to the Technical Services Manager, this role will be responsible for the management of all site validation activities on various laboratory equipment sets. Validate/qualify equipment, systems and processes in accordance with site/regulatory requirements and support, follow and implement company standards policies and procedures. Core Responsibilities: 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 co-ordinating validation schedules on site and efficient execution of both short and long-term projects. Analyse the results of testing and determine the acceptability of results against pre-determined criteria. Responsible for all associated validation documentation compliant with GMP. Prioritise 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. Investigate and troubleshoot problems which occur, and determine solutions or recommendations for changes and/or improvements. Participate in project teams and assist 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. Interested applicants should have: A minimum of 3 years’ experience in the pharmaceutical industry. Strong communication and writing skills. Good time management and planning skills. 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.

1444 days ago