Job Description
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.
We are looking for a senior-level Quality Assurance CSV Engineer to join our team.
Responsibilities
- Provide QA review and approval for computer system validation
- Provide QA review and approval for change control record
- Provide QA review and approval for incident management documentation/records for GCP computerized systems
- Provide review and approval of validation plans/reports
- Provide review and approval of user requirements specification
- Provide review and approval of design specification
- Provide review and approval of IQ/OQ/PQ tests
- Provide review and approval of validation discrepancies
- Provide review and approval of SOPs
Requirements
- 7-10 years of QA/CSV experience
- Bachelor’s degree in Life Sciences, Engineering, Computer Science or related discipline
- OR requisite combination of education, training, and experience, and 7-10 years’ experience in life sciences, regulated industry.
- Change management experience and skills
- Knowledge of Corrective and Preventative Action
- Experience with Clinical Systems
- CR Support experience
- Strong knowledge of and experience in the following validation activities: Function Requirements Specification, IQ, OQ, PQ, Network and Hardware Infrastructure Qualification, RTM, Risk-Based CSV – GAMP5, Software Development Lifecycle, SOPs, System Release/Turnover, User Acceptance Testing, User Requirement Specification, Validation Plans, Risk Assessment, Summary Reports, Vendor Audits