Manager

 
Location: Andover, Massachusetts
Posted On: 5/11/2017
Job Code: Validation_7495
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Job Description
 
Job Description: Job Title: Quality Assurance Validation Specialist Job Class: IT Technical • The individual will provide Quality Assurance oversight in support of a site MCS upgrade project. The individual will be responsible for the quality review and approval of validation documentation such as protocols, deviations, change managements, and change controls. The documentation will primarily be automation OQ testing based on DeltaV software, therefore; experience in an automated GMP environment is required. The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc. Upon completion of their review, the individual will also be responsible for the release of equipment back to GMP manufacturing. • Provide QA review of executed validation documents such as protocols, deviations, and change managements. • Ensure compliance to governing SOPs, validation plans, and protocols throughout the project. • Release equipment back to GMP manufacturing as part of change control. • Have the ability to independently assess impact and re-testing requirements in the event of a deviation. • Interactions will primarily be between engineering/validation personnel. Some interaction will also occur with operation personnel, as applicable. Release Comments: Please use the below link to begin submitting Candidates.
Category:Non-IT  code:new
 
 
Job Requirements
 
 
Management, Engineering, Change Management, Compliance, Automation, Quality Assurance
 

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Contact Details
 
Recruiter
Aditi Parihar
 
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LinkedIn
https://www.linkedin.com/in/aditiparihar/