Position Summary :
This individual will ensure the quality of enterprise manufacturing software validation activities in a Contract Development and Manufacturing Organization (CDMO) setting.
Individual will be responsible for the review and approval of enterprise software validation lifecycle deliverables and the quality oversite of change controls, CAPAs, and deviations associated with enterprise software.
Provides strategic and technical expertise for all global manufacturing software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.
Position Responsibilities :
Provide quality assurance review and approval for validation lifecycle deliverables of enterprise software projects.
Provide quality assurance review and approval of enterprise software change controls, CAPAs, and deviations.
Provide support for data integrity global initiatives.
Minimum Requirements :
BS and 8+ years’ experience or MS and 6+ years’ experience in a QA or GMP environment or equivalent.
Familiarity with manufacturing software.
Experience in Data Integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment.
Demonstrated expert knowledge of 21CFR, Part 11, and / or EU Annex 11.
Salary : $110,000 - $130,000
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range.
KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
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