Job Title: Computer System Validation Specialist
This is a challenging role that requires a high degree of expertise in Computer System Validation. The successful candidate will be responsible for ensuring that all computer systems are validated to meet regulatory standards.
Key Responsibilities:
* To develop and maintain qualification plans and test plans, aligned with the overall project C&Q plan and with the leveraging strategy.
* To review and ensure vendors compliance with quality standards.
* To provide FAT oversight and perform leveraging assessments.
* To provide guidance and support to team members tasked with delivery of SDLC documents.
* To participate in, and support, relevant project meetings.
* To liaise with various stakeholders on the overall project to ensure clear communication between all parties in relation to validation requirements.
The ideal candidate will have extensive experience in a similar role in life sciences, ideally in pharmaceutical manufacturing. They will possess expert knowledge of GAMP5 and experience in systems such as Emerson Delta V. Additionally, they will have strong interpersonal and communication skills (verbal and written).
A relevant Computer Science or Engineering degree or equivalent is required. Previous experience working with paperless validation systems (Kneat) would be advantageous.
Requirements:
* Expert knowledge of GAMP5
* Experience in systems such as Emerson Delta V
* Strong interpersonal and communication skills (verbal and written)
* Relevant Computer Science or Engineering degree or equivalent