Engineer 2 Global QA CSA
90 Digital Drive Novato, CA 94949 US
- Provide CSQA expertise and oversight of QC/BAS Analytical Instrument, Enterprise, Operations/Supply Chain and Quality computerized system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
- Provide oversight and support of the Quality Change Management process and activities associated with the implementation of new GxP computer systems and/or changes to existing validated computer systems.
- Provide guidance and support root cause analysis on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).
- Apply Risk-based methodologies across the computerized system lifecycle.
- Provide guidance and QA oversight for SDLC documents like User Requirements, Specifications and Validation/Qualification protocols and test scripts.
- Responsible for the authoring and development of Periodic Reviews Reports for computerized systems across the company.
- Provide quality oversight to support and follow the company's Data Integrity Program.
- Establish and sustain the company's computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
- Partnering with internal and external IM, QA, and Development Sciences teams; sharing information to increase the collective understanding of QA and Data Integrity programs.
- Knowledge of industry standards; 21 CFR Parts 210, 211, 11, 820, EU Annex 11, ISPE GAMP5, as it relates to computer systems used at the company.
- Ensuring alignment of processes, procedures, and methods across multiple organizations (internal and external).
- Authoring and /or revising SOPs.
- Authoring and / or revising validation documents and protocols.
- Administer applicable electronic systems.
- Assist as needed in audits and inspections.
- Contribute to projects related to CSQA improvements and system reliability.
- Development, execution, and approval of change control records.
- Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.
- BS in a Computer Science or Engineering field or equivalent experience
- 3 to 5 years’ experience in CSV in the Life-science/regulated industry
- 3 to 5 years working in the Quality area in biotech or pharma
- Experience in Deviations, CAPAs and Change Control Management
- Strong knowledge and implementation experience on industry regulations (e.g., 21CFR210, 211, 820, Part 11, Annex 11, ICH Q9, Q10) and guidance’s (e.g., ISPE GAMP, MHRA)
- Good knowledge and implementation experience on Data Integrity requirements (e.g., ALCOA & ALCOA+)
- Experience with Computer Systems Periodic Reviews
- Experience with Veeva QMS and Quality Docs
- Experience with Office 365
- Experience with SAP desirable
- Experience with ALM desirable
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