обновлено 9 дней назад
QA Auditor (Pharmaceutical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QA Auditor (Pharmaceutical) (GxP/GLP): Supporting quality assurance audits, regulatory inspections, CAPA reviews, and electronic quality management processes in a pharmaceutical laboratory with an accent on audit documentation, compliance findings, and inspection readiness. Focus on conducting audit tasks, managing eQMS records, reviewing corrective action plans, and maintaining investigator compliance information.
Location: Beijing, China
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Support lead auditors with scheduling, conducting, documenting, and closing quality assurance audits.
- Enter and categorize audit and inspection findings in the electronic quality management system (eQMS).
- Request follow-up information and manage the closure of audits and inspection findings.
- Review and approve Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans.
- Support customer audits, mock regulatory inspections, and regulatory facility inspections by reviewing documents, coordinating interviews, and tracking materials.
- Maintain the eQMS and investigator compliance repository while providing quality assurance support and consultancy.
Requirements
- Bachelor's degree preferred.
- At least 1 year of quality assurance experience in pharmaceutical, technical, or a related field, including GxP and/or quality assurance experience.
- Knowledge of GxP regulations, GLP guidelines, and quality assurance auditing techniques.
- Working knowledge of word-processing, spreadsheet, and database applications.
- Strong interpersonal, problem-solving, organizational, communication, and teamwork skills.
- Ability to work independently, manage multiple projects, and maintain effective relationships with coworkers, managers, and clients.
Culture & Benefits
- Full-time employment in a quality assurance role supporting clinical research and healthcare operations.
- Exposure to customer audits, mock regulatory inspections, and regulatory facility inspections.
- Work within established audit budgets, timelines, and compliance procedures.
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