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Biopharmaceutical Manufacturing Expert
1 week ago
At AGC Biologics, we are dedicated to bringing hope to life by enabling life-changing therapies for patients around the globe. As a leading global organization specializing in the development and manufacturing of biopharmaceutical products, we focus on delivering high-quality solutions for clinical and commercial markets.
We are seeking a highly skilled Scientist to join our dynamic QA or Manufacturing department. As a key member of our team, you will work closely with cross-functional teams, including QA, QC, and Development, to support the manufacturing of biopharmaceutical products.
Your primary responsibilities will include:
- Master Production Record Management: Create, review, and maintain Master Production Records to ensure compliance with cGMP regulations.
- Production Support: Provide on-call/shopfloor support during critical process steps and facilitate solutions during breakdowns in batch execution.
- Deviation Management: Timely close deviations, including systematic problem-solving during root cause investigations and handling other quality documents.
- Compliance: Establish and maintain procedures to ensure compliance with cGMP regulations.
- Customer Interaction: Act as a representative in customer meetings and support audits and inspections.
- Continuous Improvement: Capture learnings and implement continuous improvements to processes.
As a successful candidate, you will have a strong background in scientific or technical fields and experience in the biopharmaceutical or related industry, preferably in a cGMP environment. You will also possess excellent collaboration and communication skills, proficiency in English, and a positive attitude towards new assignments and responsibilities.
