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Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our pharmaceutical and healthcare clients, whose purpose is to reimagine medicine to improve and extend people's lives. They use innovative science and technology to address some of society's most challenging healthcare issues. They discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Job Title: QA Officer Operations

Work Location: Millburn, NJ, 07041

Duration: 12 Months

Job Type: Contract

Work Type: Onsite

Job Description:

Responsibilities include but not are limited to:

Execute and/or approve deliverables for the Site Validation Plan enabling overall strategic implementation of remediation and qualification activities within the site's commitments.
Work in close collaboration with site-based SMEs to ensure the implementation of robust, high-quality deliverables, with clear alignment between inspection SMEs and site leadership.
Review and approve actions related to facility, computerized systems, laboratory or products.
Ensure proper assessment with respect to Qualification and Validation is conducted.
Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC and other GMP support areas.
Review and approval of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters.
Support the site's Inspection Readiness program for regulatory inspections,client baseline audits /audits.
Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture.
Helps build and drive a culture of compliance throughout the organization.
Inspire change management initiatives and embed collaboration forums across the sites and as required with stakeholders.
Control project scope to limit schedule changes and to capture changes of scope that may arise.

Background:

B.S. degree in Science, Engineering or related field with 5 years' relevant experience or MSc with 3 years of relevant experience.

5 years of experience in Pharmaceutical Manufacturing preferred, at least 3 years combined of relevant experience in quality-based roles including experience in GMP and/or laboratory operations required.

TekWissen Group

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