Downstream Operations Manager
Vor 5 Tagen
We are seeking a highly skilled QA Associate to join our Integrated Downstream Quality Operations team.
In this role, you will engage in quality operations and engineering activities for downstream manufacturing and equipment at a large-scale facility. Your focus will be on ensuring product safety, efficacy, and purity through comprehensive quality assurance practices.
To be considered for this role, you must have the right to work in this location or hold an EU passport.
Responsibilities:- Execute quality assurance activities related to downstream operations and GMP manufacturing.
- Review and approve GMP Engineering and Manufacturing documents, including procedures, work instructions, CAPAs, deviations, and change control.
- Collaborate with cross-functional teams during deviation management and investigations.
- Participate in monitoring and release activities for Column Packing/Unpacking and Chromatography Review.
- Engage in batch record review and closeout for batch release.
- Bachelor's or Master's degree in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, or related fields.
- Experience in pharmaceutical or biotech manufacturing environments.
- Familiarity with Quality Assurance, Equipment Qualification, and Downstream Processes.
- Strong problem-solving capabilities.
- Proficiency in English at a B1 level or higher.
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