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Process Validation/Mfg SME

Company Name:
ALKU
Environment:
Our client is a large medical device manufacturer. They are manufacturing a number of class II and III medical devices. They are in need of process validation consultants to come in to review and remediate documentation as it relates to the manufacturing processes for their products as it relates to medical device manufacturing.

Principle Duties and Responsibilities:
The consultant will be a senior level quality /process validation consultant with 6-10+ years of experience. The consultant must be comfortable digging through the clients protocols and determining where issues are how to remediate those issues. They must be able to direct resources in the right direction as issues come up. The resources will report through the Production and Process Controls Work Stream Lead, with guidance from the Work Stream Project Manager, in regards to the due dates and deliverables.
The client uses CNC machining

Required:
Medical Device
ISO 13845
- Metal Machining (lathes, mills, CNC, etc)
21 CFR Part 820/GMP/GCP
Remediation for Manufacturing Processes/Process Validation
- GD&T/Gage R&R



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