Senior QA Release Lead: GMP & Batch Quality

Sanofi; Pennsylvania; Presencial; USD 78 000 - 113 000; Tempo integral

Resumo da oferta

Sanofi in Swiftwater, PA seeks a QA Release Senior Quality Reviewer to oversee the Batch Release Protocol (BRP) process and give final release to the market. The role involves reviewing batch release protocols for both foreign and domestic submissions, ensuring GMP compliance across the product lifecycle, and coordinating with regulatory affairs and supply chain.

You will lead disposition decisions, participate in audits and investigations, and support continuous improvement within a high‑tech

Qualificações

• Bachelor's degree in a relevant field and pharma QA experience.
• 3+ years in Quality Assurance within the pharmaceutical industry.
• Solid knowledge of GMP and QA principles.

Responsabilidades

• Ensure activities in scope comply with regulatory requirements.
• Review and approve batch release protocols and documentation.
• Coordinate with supply chain and regulatory affairs for batch release schedules.
• Perform final approval of batch release protocol product configurations.
• Support internal and external audits and regulatory inspections.

Conhecimentos

Quality Assurance

GMP knowledge

Batch records review

Data analysis

Autonomy

Microsoft Excel

Regulatory interactions

Formação académica

Bachelor's degree

Ferramentas

Microsoft Excel

PowerPoint

Word

Descrição da oferta de emprego

Sanofi in Swiftwater, PA seeks a QA Release Senior Quality Reviewer to oversee the Batch Release Protocol (BRP) process and give final release to the market. The role involves reviewing batch release protocols for both foreign and domestic submissions, ensuring GMP compliance across the product lifecycle, and coordinating with regulatory affairs and supply chain.

You will lead disposition decisions, participate in audits and investigations, and support continuous improvement within a high‑tech