Sr. Quality Specialist, Computer Systems Validation

At Proclinical, we are seeking a skilled individual to fill the role of Senior Quality Specialist, Computer Systems Validation, based in San Francisco, CA.

Responsibilities

• Participate in project teams and author, review and approve computer validation-related documentation.
• Coordinate with other departments or outside contractors/vendors to complete validation tasks.
• Support resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements.
• Investigate and troubleshoot problems which occur and determine solutions or recommendations for mitigation and/or improvements.
• Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Participate/lead in the review of current and future SDLC/CSV policies and procedures.
• Participate in regulatory audits and communicate company's computer validation policies.
• Prepare plans for remediation of legacy systems and implementation of new systems.
• Conduct validation training with project team communicating deliverables, procedures and methods.
• Manage projects and prepare status reports as applicable.
• Provide compliance support, guidance and expertise.

• Knowledge of 21CFR Part 11 and GAMP V.
• Understanding of GxP regulations and computer validation principals.
• Understanding of software development lifecycles.
• Understanding of document management principals.
• Demonstrated technical writing and oral communication skills.
• Scientific education or experience, with test script design, technical document reviews preferred.
• Knowledge of cGMPs and regulatory requirements.

Skills And Qualifications

• BA in related field and 8+ years of relevant skills and industry experience. Project management experience preferred.
• Strong knowledge of computerized system development life cycle approach is required.
• Strong written, verbal, and interpersonal communication skills.
• Ability to liaise with cross-site networked/matrixed IT and Quality functions.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 6465420152 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.