External Quality Assurance Lead

Bebeequality; São Paulo; Presencial; BRL 80.000 - 100.000; Tempo integral

Resumo da oferta

A biopharmaceutical company is seeking an External Quality Assurance Specialist in São Paulo, Brazil. This role involves overseeing Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with quality standards. Candidates should possess a Bachelor's degree in a relevant field and have 3 - 5 years of QA experience, especially in the biopharmaceutical industry. Strong knowledge of cGMP regulations and excellent communication skills are essential.

Qualificações

• 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.

Responsabilidades

• Review and approve deviations, OOS investigations, CAPAs, and change controls.
• Monitor manufacturing campaigns, production activities, and resolve issues.
• Review and approve QC/analytical results and Certificates of Analysis.

Conhecimentos

cGMP knowledge

Excellent communication

Problem-solving skills

Formação académica

Bachelor's degree in Life Sciences

Descrição da oferta de emprego

External Quality Assurance Specialist

We are seeking a highly skilled External Quality Assurance Specialist to provide oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories.

Key Responsibilities

• 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.

Required Skills and Qualifications

• 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.
• Experience with CDMO oversight, lot release, and deviation management.
• Excellent communication and problem-solving skills.