Quality Assurance Validation Specialist - Pfizer - Little Island API Plant
CPL, in conjunction with our client Pfizer, require a QA Validation Specialist to join the QA team at Pfizer's API plant in Little Island, Cork.
The QA Validation Specialists will work with the project teams to ensure that all projects transferred to the site meet site validation requirements.
- Provide validation expertise in the introduction of projects to Little Island, ensuring compliance with current industry regulations, guidelines and trends.
- Coordinate execution of validation activities on things such as equipment and utilities
- Participate in cross functional project teams and assist in determining project schedules and appropriate levels of validation.
- Provide validation position on related topics and strategy and prioritise qualification activities in line with the project schedules.
- Responsible for preparation, review and approval of validation protocols, reports, procedures, deviations, change controls and other related documents to ensure compliance to internal procedures and regulatory requirements.
- Ensure GMP compliance for validation deliverables related to site and capital projects
- Provide validation expertise and support for the development (or modification phases) of manufacturing facility, equipment/systems, Automated Systems and Computerized System.
- Provide support during internal and agency inspections, Annual Product Quality Review and in the performance of quality assessment for engineering changes.
- Primary degree in scientific discipline, preferably Chemistry or Engineering.
- Thorough working knowledge of GMP’s and regulatory expectations for manufacturing of APIs.
- A minimum of 5 years working within quality in the pharmaceutical industry, is preferred
- A minimum of 4 years validation experience is preferred.
This is an initial 12 month contract.