1 час назад
Quality Assurance Operational Specialist (Pharmaceuticals)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Operational Specialist (Pharmaceuticals): Managing deviation investigations, shopfloor quality activities, batch record review, and finished goods disposition in pharmaceutical manufacturing with an accent on GMP compliance, data integrity, and root cause analysis. Focus on reviewing manufacturing documentation, conducting quality tours, monitoring non-sterile and sterile batch release activities, and preventing recurring deviations.
Location: Cairo, Egypt; onsite
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.
What you will do
- Investigate process and specification deviations, identify root causes, and define corrective and preventive actions.
- Review batch records before market release, manage archiving, and support finished goods disposition.
- Perform routine quality tours, GEMBA activities, and process observations in manufacturing GMP areas.
- Maintain compliance with local and requirements across manufacturing areas.
- Monitor site programs covering quality culture, data integrity, APR execution, and deviations affecting non-sterile areas.
- Support HSE compliance, including SOP and change approvals, PPE use, legislation, and hazardous substance and waste segregation.
Requirements
- Bachelor’s degree in pharmaceutical science.
- 3–5 years of related experience in pharmaceutical quality assurance.
- Experience with shopfloor activities, QA documentation, and compliance systems.
- Expertise in the pharmaceutical industry and raw materials, including API and non-API materials.
- Experience with deviation management, risk management, and root cause analysis tools.
- Strong decision-making and problem-solving skills.
Culture & Benefits
- Work in an R&D-driven biopharmaceutical environment focused on medicines and vaccines.
- Commitment to equal opportunity and inclusion across diverse backgrounds and locations.
- Responsibilities follow applicable HSE policies, requirements, and statutory legislation.
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