обновлено 6 дней назад
Senior Specialist, QA (Mfg Support)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Specialist, QA (Mfg Support) (Biopharmaceutical GMP): Providing quality assurance oversight for manufacturing activities in a multi-product GMP biopharmaceutical facility with an accent on batch documentation, quality systems, and regulatory compliance. Focus on leading deviation investigations, change controls, CAPA activities, audit support, and resolving operational quality issues during shift-based manufacturing operations.
Location: Tuas, Singapore; shift work required
Company
is a global life sciences company operating connected manufacturing sites to help produce medicines and therapies.
What you will do
- Provide daily QA oversight and support for manufacturing activities under SOPs, policies, and GxP standards.
- Review and approve SOPs, protocols, reports, batch records, logbooks, and other quality documents.
- Evaluate batch records, support changeovers, and compile lot genealogy for batch disposition.
- Lead or participate in deviation investigations, change controls, CAPA processes, and discrepancy report closure.
- Resolve quality and operational issues, manage small-scale projects, and coordinate with internal teams and external partners.
- Support regulatory inspections and customer audits while developing as a GxP auditor and Qualified Trainer.
Requirements
- Bachelor’s degree with relevant Quality Assurance experience in the biopharmaceutical sector.
- Experience in QA operations within a GMP-regulated biopharmaceutical environment.
- Practical experience working with cross-functional manufacturing teams.
- Knowledge of quality management systems, GMP compliance, and FDA, EMA, and ICH guidelines.
- Strong analytical, problem-solving, communication, organizational, and teamwork skills.
- Detail-oriented approach with a focus on safety, quality, and timely delivery.
Culture & Benefits
- Agile and dynamic working culture in a global life sciences organization.
- Inclusive and ethical workplace focused on diversity and integrity.
- Professional growth through cross-functional projects and global exposure.
- Comprehensive medical insurance with partially subsidized family coverage.
- Company transport from designated MRT locations to and from the Tuas site.
- Access to ’s employee benefits and competitive compensation programs.
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