Quality Assurance Specialist III
4 weeks ago
At PSG Global Solutions Careers, we are seeking a highly skilled QC Associate III to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the site policies and regulatory requirements are followed for computer system commissioning, qualification, and validation projects on site.
Key Responsibilities:- Provide Quality & Compliance oversight to site qualification/validation projects related to installations, changes, and upgrades to automated systems.
- Ensure site policies and regulatory requirements are followed for computer system commissioning, qualification, and validation projects on site.
- Participate in project teams and review and approve computer validation-related documentation for automated systems, including but not limited to Validation Plans, User Requirements, Specifications, FATs, SATs, IOQs, and PQs.
- Signatory responsibilities for all qualifications/validation issues associated with assigned areas.
Our client is an award-winning clinical development company with 20+ years of experience in clinical research and strategic resourcing. They are committed to improving lives globally and have a strong reputation for delivering high-quality results.
Requirements:- Bachelor's degree in Engineering, Computers, or a related field.
- Minimum of 5 years of experience in a GMP-regulated environment working on validation of automated systems.
- Broad experience and knowledge in the following areas: Knowledge of 21CFR Part 11, Annex 11, and GAMP V.
- Experience in commissioning and qualification of control systems.
- Experience with a variety of control systems, including DCS, PLCs, and SCADA.
- Experience with HMI SCADA systems, such as iFIX, Rockwell RSView, and Wonderware.
- Experience with Batch Systems, such as Proficy batch execution and RSBatch.
- Experience with PLCs, such as Rockwell GE Fanuc, Siemens, and Modicon.
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