обновлено 18 часов назад
Data Integrity Expert (Pharmaceutical Manufacturing)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Data Integrity Expert (Pharmaceutical Manufacturing): Ensuring data integrity across site operations in a GMP-regulated manufacturing environment with an accent on ALCOA+, GxP compliance, computerized system validation, and audit readiness. Focus on investigating data integrity incidents, implementing CAPA, strengthening documentation practices, and leading continuous improvement initiatives.
Location: Hybrid, Waterford, Ireland
Company
is hiring for a data integrity role supporting regulated site operations.
What you will do
- Ensure compliance with regulatory requirements and company policies related to data integrity.
- Perform routine data quality checks and validations, investigate incidents, and implement corrective and preventive actions.
- Develop and deliver training on data integrity principles and best practices.
- Assess data integrity risks, define mitigation strategies, and lead continuous improvement initiatives.
- Oversee computerized system validation and ensure appropriate data recording, storage, retrieval, and documentation.
- Prepare data integrity reports and metrics, support inspection readiness, and participate in audits and regulatory inspections.
Requirements
- Bachelor’s degree in science, engineering, pharmacy, quality, or a related discipline.
- 5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment.
- Strong knowledge of data integrity principles, including ALCOA+ and applicable GxP regulations.
- Experience with computerized system validation, electronic quality systems, investigations, risk assessments, and CAPA.
- Experience supporting regulatory inspections and internal or external audits.
- Strong communication, analytical, problem-solving, prioritization, and collaboration skills.
Culture & Benefits
- Permanent or contract engagement options are available.
- Hybrid work arrangement in Waterford, Ireland.
- Opportunity to represent the site in global data integrity forums and communicate updates across site functions.
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