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QA Consultant for Drug Substance
Job Summary
A company is looking for a QA Consultant (Drug Substance) to support early-phase programs and ensure compliance with GMP regulations.
Key Responsibilities
- Support QA systems and activities including change control, deviation management, and quality risk management
- Assist with CDMO lifecycle activities and collaborate with internal teams to resolve quality issues
- Contribute to CAPA and quality risk systems to ensure compliance risk identification and support product release across various jurisdictions
Required Qualifications
- Bachelor's degree in a relevant field with 5-8 years of QA experience focused on drug substance for early phase programs
- Prior experience supporting API development, chemical synthesis, and manufacturing
- Strong background in reviewing DS and API documentation including batch records and deviations
- Ability to conduct audits and develop CAPAs while identifying root causes and mitigating risks
- In-depth knowledge of global GMP regulations and industry standards
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COMPLETE JOB DESCRIPTION
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