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Validation Consultant Job
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| Employer Name: |
SpiderID: 13728441 |
| Location: Danvers, Massachusetts |
Date Posted: 4/22/2024 |
| Wage: 56$ |
Category: Medical/Health |
| Job Code: |
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| Number Of Openings: 1 |
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Job Description:
· Analyze and summarize the results of various Installation, Performance, Operational qualification (IQ/OQ/PQ) activities using valid statistical practices within the Engineering Quality Management System (QMS).
· Assist or lead in the creation and qualification of test methods and Test Method Validation (TMV), Design of Experiments (DOE) and other activities that determine the systematic suitability of a product.
· Develop & communicate expectations for quality performance, continuous improvement, quality systems, and process controls infrastructure for critical sustaining parts and new products.
· Develop and execute IQ, OQ and PQ protocols to ensure compliance with the Engineering Quality System and customer requirements for product, processes, facilities, software, and equipment within the facility and / or contract manufacturer.
· Develop and execute the Validation Master Plan, covering internal and external operations and key processes.
· Develop and execute Validation programs for internal and external operations.
· Participate in, or lead, cross-functional teams as needed to transfer products between Plants or to contract manufacturers and to implement or execute programs and that will assist with those transfers.
· Participate in, or lead, cross-functional teams as needed to transfer products from development to production and to implement or execute programs and activities that will assist in the development or improvement of products and processes.
· Refine standard validation practices to ensure that all practices are efficient and current with industry and regulatory requirements.
· Review documentation, manufacturing practices, engineering change orders, and procedure changes for quality requirements and compliance with the engineering quality system.
· Review existing validation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
· Support project teams to assist the qualification of process changes.
· Train and coach local plant validation resources to ensure knowledge transfer, understanding and timely V V activities.
· Other tasks as required by management or as needed to support business continuity.
Job Requirements:
Bachelor's Degree is required in Mechanical Engineering or Engineering Management.
Job Criteria:
Start Date: 4/29/2024
Position Type: Full-Time Permanent
Years of Experience Required: 1
Education Required: Masters
Overnight Travel:
Vacation Time:
Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave
Contact Information:
| Contact Name: Rashmi Kumari |
Company Type: |
| Company: ND Global Consulting Services Inc |
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| City: McKinney |
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| State: Texas |
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| Zip: 75070 |
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Web Site: https://www.ndgcs.com
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