Lead Equipment and Computerized Validation
Drive the revalidation of priority lab equipment and computerized systems at the Seattle site.
Ensure laboratory equipment and software life cycle management is carried out according to business strategy and internal procedures.
Lead multiple validation projects and coordinate their timely delivery with key stakeholders and external collaborators (team members, validation consultants, QA, IT, scientists, vendors).
Write/Review/Approve validation deliverables (VP, URS, FS, RA, DS, UTCR, IQ/OQ/PQ TM, VR, etc.) and ensure qualification execution according to business priorities and internal procedures.
Write, review, finalize and coordinate the approval of support operation documentation (e.g. procedures, internal audits, periodic reviews, deviation reports, service contracts) according to internal procedure and priorities;
Collaborate with support team to clarify lab equipment and computerized system validation strategies to ensure they are properly validated/maintained for indented use (e.g. repair, move, upgrade)
Excellent individual and team-work, service oriented and organizational skills.
High focus required in order to execute complex interventions autonomously.
Ability to work methodically with a concern for precision and accuracy.
Excellent analytical and problem-solving skills.
Proficient with office tools (Project, Visio, Outlook, Excel, Word, Power point). Fluently bilingual in English and French (both oral and written
Perform the functions of the position, including the ability to maintain rigorous and accurate documentation.
Apply clinical trial, laboratory, and pharmaceutical processes and protocols.
Apply quality assurance processes and procedures, data storage and retrieval steps. Work collaboratively and follow processes and procedures.
Bachelor's degree in life sciences or engineering
Minimum 5 years' experience working in a regulated pharmaceutical environment.
Minimum 4 years' experience validating computerized systems and laboratory equipment for regulated use.
Minimum 2 years' experience supervising personnel
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
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