A Senior CSV Engineer is required by CareerWise Recruitment for our client in South County Dublin, initial 12 month contract on offer. Please contact Diarmuid Buckley for full details
Role of this position
- Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.
- Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards.
- Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
- Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
- Review and Approve validation protocols and assessments from a quality system documentation perspective.
- Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS's), and any other associated validation issues.
- Participate and communicate as required in project activities.
- Develop procedures to manage computerised systems where required
- Develop and present project plans to project management senior staff
- Bachelor of Science/Engineering degree or equivalent.
- Ideally 5 years experience in a cGMP Regulated Environment:
- Computer system validation lifecycle
- Working knowledge of GAMP software development lifecycle
Please call Diarmuid Buckley for further information on 021 4355432 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)