Quality Validation Specialist

Our client - a multinational biotechnology research and development company is looking to hire a Quality validation specialist(computer Systems) for a 12-month contract.

Reporting to the Computer System Validation Site Lead you will be responsible for senior computer system validation specialist will ensure all computerized systems used to support GMP operations are appropriately validated and controlled.

Size of team : 5-10
Location :
Broadmeadows, majority of work onsite.
Contract duration :12 months with a view for another 12 months extension.
Main Responsibilities and Accountabilities :
Collaborate with Site and Global validation team to build alignment of ES validation expectations. Collaborate with ES Project Execution team to ensure the oversite of CSV activities associated with the project. Provide support of change management procedures and processes in collaboration with Quality. Support of the ES validation strategy/validation master plan in alignment with the Quality Organization. Accountable for the preparation, delivery, and execution of CSV owned validation protocols. Responsible for the System Development Lifecycle and validated the state of ES owned platforms. Ownership of investigations, CAPAs and quality and compliance KPIs. Responsible for Data Integrity Assessment execution. Responsible for the Document Periodic Review process Skills and Experience required for the role :
4-5 years' experience with CSV methodologies in operation IT, OT, and Automation position with a good understanding of pharma, biotechnology, chemistry, and foodindustries. Demonstrated knowledge and experience with CSV regulations and SDLC guidelines for lifesciences and related best practices for compliance and riskbased approach. Experience with Automation and MES projects and computer validation methodologies. Experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ) and CSV inspection readiness preparations and/or directly support regulatory agency inspections. Understanding of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5
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