Net2Source (N2S)Net2Source, Inc. is one of the fastest growing IT Consulting company across the USA. N2S is headquartered at NJ, USA with its branch offices in Asia Pacific Region. N2S offers a wide gamut of consulting solutions customized to client needs including staffing, training and technology.
Andover MA The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various computer validation testing documents, deviations, and change controls in relation to DI remediation activities.
The documentation will span the breadth of validation and change control requirements for biopharmaceutical processing therefore validation and quality assurance experience in an manufacturing 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 change controls, protocols and test plans, validation testing documents, and deviations.
Ensure compliance to governing SOPs, validation plans, and protocols throughout the project.
Release equipment back to GMP manufacturing as part of change control.
Can independently assess impact and re-testing requirements in the event of a deviation.
Proficient in reviewing executed validation documents (change controls, protocols and test plans, validation testing documents, deviations, etc.)
Knowledge of cGMP regulations as they pertain to the pharmaceutical/biopharmaceutical industry.
Thorough understanding of the computer validation lifecycle, including change control.
Identify and address any potential quality impact throughout the project.
Experience with change control as a Quality Assurance approver.
Bachelor's Degree in engineering or life sciences
5 years of computer validation/QA experience in a GMP environment
1 year of experience with Track wise change control software (or similar)
Visa Sponsorship is currently not available for this role, visa independent candidates who can work on W2 are encouraged to apply for the role.
About Net2Source, Inc.
Net2Source is an employer-of-choice for over 2200+ consultants across the globe. We recruit top-notch talent for over 40 Fortune and Government clients coast-to-coast across the U.S. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us
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Net2Source Inc. is one of the fastest growing Global Workforce Solutions company with a growth of 100% YoY for last consecutive 3 years with over 2200+ employees globally and 30 locations in US and operations in 20 countries.
With an experience of over a decade we offer unmatched workforce solutions to our clients by developing an in-depth understanding of their business needs.
We specialize in Contingent hiring, Direct Hires, Statement of Work, Payroll Management, IC Compliance, VMS, RPO and Managed IT Services.
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