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CGT QA & Compliance Lead - Product Release
Descrizione del lavoro
A global leader in life sciences is seeking a Specialist, QA (CGT) in Singapore. This role supports Quality Assurance activities in a cGMP environment, ensuring timely release of products. Candidates should have a degree in Science or Engineering and significant experience in Quality Assurance within a cGMP manufacturing setting. This position offers a dynamic and inclusive work culture along with comprehensive benefits.
Servizi
Competenze
- Experience in Quality Assurance within a cGMP manufacturing environment, ideally in Cell and Gene Therapy (CGT) or biopharmaceuticals.
- Strong knowledge of cGMP, GDocP, and applicable regulatory requirements.
- Proven ability to lead investigations, change controls, and cross-functional projects.
Mansioni
- Review executed batch records to ensure compliance with cGMP.
- Compile lot genealogy and disposition packages to drive timely product release.
- Provide QA oversight for product status and shipping documents.
- Support and approve deviation investigations and CAPA implementation.
- Oversee changes to operational documents like MBRs and SOPs.
- Participate in QA shopfloor activities and audits.
- Lead and coordinate site projects and change controls.
Conoscenze
Formazione
* Il benchmark retributivo si basa sugli obiettivi retributivi dei leader del mercato nei rispettivi settori. È pensato per orientare gli utenti Premium nella valutazione delle posizioni aperte e aiutarli a negoziare la propria retribuzione. Tale benchmark non è fornito direttamente dall'azienda, quindi la retribuzione effettiva potrà risultare anche notevolmente superiore o inferiore.