CSV / Data Integrity Specialist

at  SimoTech

ABOUT SIMOTECH

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

QUALIFICATIONS

• Bachelor’s Degree in Engineering, Information Systems, Computer Science or Life Sciences.
• Minimum 5 years’ experience working on Computer System Validation process and Data Integrity Experience working in regulated GMP environment.
• Good understanding of quality processes in IT and applying it to manufacturing and distribution.
• Strong analytical and problem-solving skills to identify and resolve technical issues related to laboratory systems, configurations and integrations.
• Familiarity with cybersecurity concepts, best practices, and experience working in an Agile environment is highly advantageous.
• Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.

• Responsible for implementing a data integrity culture and CSV strategies at the site, ensuring compliance with global and local regulatory requirements for systems.
• Lead the implementation of technology solutions to improve Data Integrity and CSV compliance.
• Be the site representative in Data Integrity/CSV- related deviations and CAPAs.
• Coordinate technical evaluations of new and existing systems from a Data Integrity and CSV compliance perspective.
• Assist in clearly defining CSV requirements for third-party service providers.
• Collaborate and establish best practices and evaluate new considerations for technology use at the site.
• Partner with leadership to conduct gap analysis and remediate efforts related to Data Integrity, LQPs, GQS, SOPs and CSV.
• Provide support during internal, external and regulatory audits.
• Work cross functionally with site Data Integrity SMEs to ensure a systematic approach to meeting Data Integrity and CSV expectations including audit trail management and workstation security.
• Ensure information assets are protected from malicious content and access information is restricted to authorised personnel only.