SalaryUSD TBD TBD
- Provide interpretation and guidance regarding qualification and validation requirements in GLP-, Google Cloud Platform- and GMP-regulated areas of an R&D organization.
- 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.
- Provide assurance that applicable national and international regulatory requirements are adhered to in the context of validation and qualification policies, processes, and procedures.
- Lead or participate on process improvement projects and assist with the development of compliance plans and strategies.
- Review new / updated regulations and provide comments on and assessments of how the new / updated regulations impact the organization.
- Participate in preparation and execution of authority inspections, self- inspections, vendor audits, presentation of validation concepts and system validations.
- Minimum of 5 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, Data Integrity, etc.)
- Conducting or providing QA oversight of Equipment, Facility, Utility, Instrument qualification and Cleaning, Automated Process Controller, and Test Method validation.
- Excellent communication capabilities and teamwork capacities.
- Proven ability to work in a global environment and on virtual teams.
Systems Engineer-File Share Admin/ NTFS/ NetApp