4 year college degree; preferably a BS in Computer Science, Chemistry, Biology, Engineering Pharmacy, or Microbiology. Minimum of 8+ years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation or compliance. Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.). Conducting or providing QA oversight of Equipment, Facility, Utility, Instrument qualification and Cleaning, Automated Process Controller, Qualification and Validation. Excellent communication capabilities and teamwork capacities. Proven ability to work in a global environment and on virtual teams. Major Job Responsibilities: Provide interpretation, guidance, and training for clients regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization. Author, Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision. Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.). Support CAPA activities related to validation and qualification. Provide guidance, direction, and support to peers.Experience with Veeva Vault, Waters Empower, LIMS is preferred.Solid understanding of Computer Systems Validation.Technical knowledge in Oracle, SQL Server, SQL, PL/SQL, Windows Servers, Webservers, Web Application, client/server, Cloud applications and SaaS models.Local candidate only for this position please.
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering