Description
We are looking for Validation Consultant as per the details given below:
Location: Foster City, CA
Number of positions: 2
Star Date: ASAP
Duration: 6-9 months
Data migration Interface testing Validation Consultant
Familiarity with a tool called TruCompare would be a huge plus.
- 7+ years experience in Quality & Compliance with a Bachelors degree.
- Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
- Experience in Computer system validation.
- Experience in reviewing system test and user acceptance test scripts, Traceability Matrix and Design Specs.
- Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/validation reports.
- Experience in Software Development Lifecycle (SDLC).
- Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
- Experience in Change Control.
- Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)
- Experience is creation of SOPs.
- Knowledge of FDA guidance's and industry standards (ie, GAMP)
- Hands on experience in HP Quality Center and QTP.
- Strong verbal and written communication skills.
- Able to work as a team player, lead a team or accomplish tasks without supervision.
- Ability to work with remote teams and support several changes/projects simultaneously.
- Flexibility to work with an onshore/offshore model.
- Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies
- and to ensure systems to be developed adhere to corporate SDLC methodology.
- Drive understanding and adoption of Quality and Compliance standards.
- Ensure Quality & Compliance requirements are considered in any initiative or major change request.
- Ensure the compliance deliverables are updated and kept current with all applicable changes.
Please send in your updated Resume in Word format along with rate expected/hour and contact details.