Validation Specialist
VST15446_1719309877
Posted: 25/06/2024
- £60000 - £65000 PER ANNUM
- Netherlands
- Contract
Validation Specialist - Netherlands
Annual Salary: €60,000 - €65,000
Contract Type: 6 -month contract
Work Schedule: Full-time hybrid role, minimum 3 days on-site Hoofddorp, Netherlands.
Description: Join a leading biopharmaceutical company dedicated to innovation in cancer treatment. We are seeking a dedicated Validation Specialist to support routine validation activities and validation projects.
Responsibilities:
- Perform routine validation activities and support validation projects.
- Create and execute commissioning, qualification, and validation protocols (CP/IQ/OQ/PQ), including resolving exceptional conditions.
- Conduct temperature mapping and other validation activities.
- Investigate and implement corrective actions related to protocol exceptional conditions.
- Coordinate validation instrument inventory calibrations and/or certifications.
- Support vendor protocol executions as necessary.
- Create Computerized System Validation (CSV) documents, including risk assessments, validation project plans, user acceptance tests, and reports.
- Collaborate with Quality Engineering to develop CSV strategies and procedures.
- Provide guidance and execute strategies for computerized system, equipment, utility system, and facility commissioning and qualification during project planning and development phases.
- Review technical documentation, including protocols, summary reports for CSV and CQV lifecycle documentation, and other testing and validation SOPs.
- Report the status and progress of qualification activities or projects to the Leadership team.
- Manage contractors performing equipment and system commissioning, qualifications, and validation.
- Develop or review technical specifications documents necessary for CQV lifecycle documentation.
- Perform investigations and implement corrective actions related to CAPAs and deviations.
- Additional duties as assigned.
Qualifications:
- MBO level 4 with at least 6 years of experience or HBO with at least 4 years of experience.
- GMP experience in pharmaceutical or relevant industries.
- Validation experience.
Additional Information:
- Working Hours: Business Hours (40hrs/week), with flexibility when required.
- On-site Days: Minimum 3 days on-site.
- Extension Possibilities: Yes.
- Language Skills: English mandatory, other languages beneficial.
Join us in advancing cancer treatment through precise validation and compliance activities.
Send your CV to cosman@i-pharmconsulting.com or call +442075510737. Refer someone and earn a £500 referral bonus upon their successful placement.
We welcome all qualified candidates and are committed to an inclusive environment. We look forward to hearing from you!
