2 дня назад
Senior QA Specialist (Investigations)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior QA Specialist (Investigations) (GMP/Pharmaceutical Quality): Providing QA oversight for manufacturing and laboratory investigations, CAPA, batch controls, and quality systems with an accent on GMP compliance, root cause analysis, and regulatory readiness. Focus on managing investigation systems, assessing quality and regulatory impacts, analyzing trends, and maintaining validated processes at a pharmaceutical manufacturing site.
Location: Tuas, Singapore; onsite manufacturing site role
Company
is a pharmaceutical company focused on developing and manufacturing safe, effective products for patients.
What you will do
- Provide QA oversight for GMP manufacturing and laboratory investigations, including batch holds, quarantine notifications, and management notifications.
- Review and approve investigation reports, manufacturing records, CAPA, effectiveness checks, and related quality, validation, stability, and regulatory impact assessments.
- Own site investigation-related quality systems and procedures, representing the site in global Process Centric Teams.
- Train and mentor QA personnel, including investigation approvers and junior team members.
- Analyze trends and metrics, recommend improvements, and support inspection readiness, mock recalls, market actions, and GMP walkdowns.
- Support validated GMP systems, quality risk management, continuous improvement, and Environmental, Health and Safety investigations.
Requirements
- Degree in Chemistry, Microbiology, Engineering, or another science-related discipline.
- Minimum 4 years of experience, including QA experience, in the pharmaceutical industry.
- Ability to resolve issues independently, escalate appropriately, and work effectively in cross-functional teams.
- Strong written and verbal communication skills, personal leadership, accountability, and organizational skills.
- Experience with compliance, regulatory, validation, technical report writing, or matrix environments is advantageous.
Culture & Benefits
- Work within a quality-focused, risk-based, compliant GMP culture.
- Contribute to continuous improvement and the development of a best-in-class manufacturing site.
- Use digital quality systems and structured Tier processes to monitor performance and resolve issues.
- Support ’s quality standards, Code of Conduct, safety initiatives, and patient-focused mission.
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