Mammalian QA Expert
7 days ago
About Us:
AGC Inc. is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.
The QA Mammalian Team:
The QA Mammalian team is characterized by positive and proactive colleagues who meet deadlines through committed and friendly collaboration. We have an open communication culture with a focus on high professionalism, open-mindedness, and a high service level for our colleagues and international customers.
Job Description:
We are seeking a Senior Scientist to join our QA Mammalian team. The ideal candidate will have a Master's degree in a relevant Science field and a minimum of 3-5 years of relevant GMP experience. They will be responsible for ensuring the quality of our biotechnological production, working closely with scientists and principal scientists with various professional backgrounds and years of experience.
Responsibilities:
- Ensure resolution of significant quality issues.
- Responsible for the overall Quality Assurance review and approval of technical documents.
- Support the generation of new SOPs and improvement of existing ones.
- Support delivery of AGC projects.
- Support client audits and assist with negotiation terms of Quality agreements as required.
- Liaise with internal and external stakeholders to resolve and clarify any point of issue.
- Assist with the generation of APQR (Annual Product Quality Review).
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