External Quality Assurance Lead

Há 13 horas


Brasília DF, Brasil beBeeQuality Tempo inteiro

External Quality Assurance Specialist About the Role: The External Quality Assurance (EQA) Specialist will provide oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role is critical in supporting ongoing manufacturing campaigns, batch release, and ensuring timely resolution of quality events. Review and approve deviations, Out-of-Specification (OOS) investigations, CAPAs, and change controls from CDMOs and external testing laboratories. Monitor manufacturing campaigns, production activities, and resolve issues during routine manufacturing. Review and approve QC/analytical results and Certificates of Analysis from CDMOs/external labs. Review and approve production lot records for compliance prior to disposition. Perform GMP reviews of incoming documentation (batch records, test data, release packages). Ensure timely escalation and resolution of manufacturing and quality issues. Collaborate with internal cross-functional teams (QA, QC, Supply Chain, Regulatory, CMC) to ensure readiness for release and regulatory filings. Support audit readiness activities for Regulatory Authority inspections. Requirements: Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline. 3 - 5 years of QA experience in the biopharmaceutical or cell/gene therapy industry. Strong knowledge of cGMP, ICH Q7/Q10, FDA 21 CFR Parts 210/211. Experience with CDMO oversight, lot release, and deviation management. Excellent communication and problem-solving skills. What We Offer: A dynamic and collaborative work environment. Opportunities for professional growth and development. Competitive compensation and benefits package.



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