SERIALISATION CSV ENGINEER: CORK
TARGET START DATE: ASAP
LENGTH OF ASSIGNMENT: 12 months
KPC International is currently working with our client, a Cork-based multinational pharmaceutical company, on the provision of a CSV Engineer with expertise in Serialisation projects. Reporting to the automation project lead, this role will support Computer/Automation System Validation (CSV/ASV) and data integrity projects with key focus around customer specification, Validation Master Plan, protocols and reports. This person will provide the company with the technical and validation resource to manage the validation deliverables on selected projects and will coordinate the necessary activities for ensuring the timely closure of validation activities on projects.
- Plan, coordinate and participate in a compliant validation process for quality information technology systems which requires formal validation documentation (FAT, SAT, IQ, OQ and PQ) under appropriate regulatory requirements and company manufacturing standards.
- Generation of project Validation Master Plans.
- Review and approval of third party generated protocols and reports
- Participate in data integrity risk assessments and / or Design FMEAs.
- Analyze the results of testing and determine the acceptability of results against predetermined criteria.
- Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
- Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
REQUIREMENTS FOR THE ROLE:
- Science or engineering degree with minimum of 5 years’ experience
- Prior experience of working on Serialisation projects in a regulated environment
- Enthusiastic and energetic with the ability to integrate quickly into a team environment.
- Demonstrated flexible and innovative approach to work.
- Strong knowledge in data integrity
- Familiar with SDLC based on GAMP 5
- A thorough working knowledge of quality systems such as ISO 13485/21 CFR Part 820/21 CFR Part 11/ Annex 11 is essential.
To find out more about this new opportunity, please send your CV to email@example.com or for a confidential conversation call Eoin Collins on +353 21 2363152