
Quality Assurance Specialist
1 week ago
We are seeking an experienced Quality Assurance Specialist to join our team. This key role will ensure the quality and integrity of our sterile injectable products.
- Key Responsibilities:
- Validate manufacturing processes and equipment to guarantee compliance with regulatory requirements.
- Analyze results from media fill studies, identify areas for improvement, and recommend corrective actions.
- Prepare and review area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data.
- Support Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
- Essential Qualifications:
- A deep understanding of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory guidelines.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
This role offers opportunities for professional growth and development within our organization.
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