QA Consultant for Drug Substance
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
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
