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Quality & Regulatory Systems Implementation Consultant - Life Sciences - Senior - Consulting
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$82,800 - $136,600 a year
Full-time
- Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.)
- Regulatory Affairs (regulatory submissions, Health Registration Management, etc.)
- In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.
- Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution.
- Performing Quality audits of client processes within the QMS area.
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