Validation Specialists - Secondary Pharma - North West - Contract
Our client is a leading pharmaceutical organisation. At present they are seeking contract resource to conduct validation activities relating to either utilities, facilities, equipment, steaming or cleaning validation in a secondary manufacturer (filling/inspection/packaging), ensuring that resource, raw materials and documentation are available at the appropriate time to ensure that validation activities run smoothly and meet critical path due dates.
- Plan and prioritise own workload to ensure that agreed deadlines are met. This includes coordinating and performing validation activities, tracking and reporting the progress of activities to the validation, process and QA leaders, managing priorities and anticipating and removing obstacles to progress. This also includes working with external vendors and other cross functional departments on and off site.
- Accountable for delivering execution and completion of validation activities
- Create, execute and report validation documentation to meet regulatory and company standards.
- Contribute effectively to solve both GMP and business issues and deviations supporting cross functional team and effectively support other functions within the segment when required.
- Have specialist knowledge in specific areas of validation, GMP and/or processes particularly relating to secondary aseptic manufacturing and filling/inspection/packaging lines. Also to have a breadth of validation knowledge to allow adaptability to the different types of validation conducted within the segment.
- Training non-validation personnel to support execution of validation exercises.
- Assist with the presentation of validation during customer and regulatory audits.