QA approver for internal computer system validation efforts. Act as liaison to the business for guidance and consultancy on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support health authority audits/inspections for inspection readiness. Requirements. Bachelor’s degree in associated functional disciplines including IT, Data Sciences and others. Software development familiarity with both ... more details
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Essential Functions
QA approver for internal computer system validation efforts. Act as liaison to the business for guidance and consultancy on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support health authority audits/inspections for inspection readiness.
Requirements
Bachelor’s degree in associated functional disciplines including IT, Data Sciences and others.
Software development familiarity with both Agile and Waterfall methodology.
Knowledge of coding matrix and complexity measurements/determination.
Minimum 8 years experience in Pharmaceutical industry or similar.
Familiarity with regulations governing software development and validation.
Knowledge of Statistical Programming is preferred but not required.
Knowledge of GCP/GMP is preferred.
Auditing experience is preferred but not required.
Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
Ability to Travel (approximately 10-20%).
Location: Nutley (hybrid role)
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Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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