Company: Hydrogen Group
Closing Date: 26 Dec 16
Salary (£): Negotiable
This is an incredible opportunity for a skilled computerized System Validation engineer to be in charge for new biopharmaceutical processes. Our ideal candidate has an open and communicative personality and enjoys being part of a dynamic team. She or he is a motivated team player, flexible and driven to produce work of high quality.
Computerized System Validation Engineer
Processes: Vaccines development – USP –DSP and Fill Finish Processes.
Work hours: 40h/week
The aim of this position is to be in charge for the computerized System Validation for new biopharmaceutical processes.
She/he must ensure that:
• The computerized system validations are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
• Planning, coordination and execution of all phases for computerized System validation
• Review and evaluation of validation results
• Preparation of GMP-compliance documentation for computerized System validation
• Performance of risk/criticality assessments
• Presentation, as subject matter expert, of the domain of responsibility during inspections and audits.
• Degree: Master/Bachelor in natural sciences, degree in applied sciences or equivalent.
• Profound know how of computerized System Validation
• Ensure compliance with 21 CFR Part 11 requirements and predicate GxP standards through integrated quality reviews of all computer system validation processes, procedures and documentation.
• Writing and reviewing system validation and testing plans, validation and test summaries and reports, user acceptance test plans, traceability matrices, test defect reports and IQ/OQ/PQ protocols and test scripts.
• Implement validation assessments and gap analyses ensuring compliance with 21 CFR Part 11 requirements and predicate GxP standards
• Experience in inspection of regulatory agencies
• Analytical thinking and problem-solving ability.
30 Eastcheap London
|Tel:||+44 (0) 207 002 0000|
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