Governance and Assurance Specialist
CompliancePath – Validation Acceleration /
•Work with CompliancePath Head of Validation Acceleration (or deputy) to support validation projects
•Review software systems used in quality processes to determine appropriate validation requirements to meet global GxP regulatory requirements.
•Lead Computer System Validation efforts related to authoring and executing specifications and validation documentation for computer systems, in alignment with Good Manufacturing Practices (GMPs),
•Reviews computer system validation documentation, to ensure data integrity requirements are maintained.
•At least 3 years of experience with software validation, preferably in a GxP environment.
•General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of manufacturing and QC processes and how they relate to regulatory requirements.
•Experience testing, and creating validation documents
•Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.)
•Experience in writing and execution of IQ, OQ and PQ for GMP Systems and Software
Solid line reporting into CompliancePath Head of Validation Acceleration
No direct or indirect reports
Specific Professional Abilities:
•Ability to self motivate and work remotely
•Ability to explain and discuss regulations.
•Ability to manage multiple tasks, in a timely and positive manner
•Willing and able to very occasionally do business travel (including staying away): mainly The UK, US & EU.
Specific Environmental Factors:
•Degree in a science/health-related subject.
•Fluency in written and spoken English
•Willing to develop an Understanding of EU GDP, EU GMP and Quality Management Systems
•Ability to communicate and negotiate with peers
•Willing to develop an understanding of local and European regulatory environments
•Good organizational, coordination, diplomatic, negotiation, presentation and communications skills
•Precise, rigorous and reliable with an analytical mind
•Good decision making skills
•Quality Assurance experience within the pharmaceutical industry is an advantage
•Experienced in handling regulatory interfaces such as inspections and audits is an advantage