
Third-Party Product Quality Assurance Specialist
2 weeks ago
As a Quality Assurance Specialist, you will be responsible for ensuring the quality of products manufactured by third-party companies.
This role offers an exciting opportunity to work in a dynamic environment with multiple stakeholders across various departments.
- Compile and review batch documents prior to QP review.
- Collaborate with responsible sites to complete corrections and prepare COC for QP.
- Perform reviews of batches manufactured/packed at PCI or in third-party companies, identifying deviations and initiating corrective actions as needed.
- Request and review certificates of analysis/conformance for API/drug substance, bulk product, packaging records from customers/suppliers against approved filing/dossier.
- C Coordinate product supply chain flows and participate in customer meetings to discuss quality documentation.
- Develop SOPs or work instructions and maintain batch documents and retain samples in archive rooms.
- Maintain safe work practices and report any near misses to the EHS Department immediately.
The ideal candidate will possess a degree and/or relevant experience, GMP knowledge, steriles expertise, strong communication skills, problem-solving ability, and capability to set clear goals and ensure progress to completion meeting predefined targets.
Minimum 2 years' experience working in Quality Assurance is required, along with a proven track record of delivering results through management/leadership of others.
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