
Sterile Product Quality Assurance Expert
9 hours ago
Job Title:
Quality Assurance SpecialistDescription:
We are seeking a highly skilled Quality Assurance Specialist to ensure the quality and integrity of our sterile injectable manufacturing processes.
- Main Responsibilities:
- Analyze media fill results, identify deficiencies, and recommend corrective or preventive actions.
- Prepare area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.
- Prepare periodic requalification protocols, data, and environmental monitoring summaries for compliance with regulatory requirements.
- Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
- Prepare utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
- Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.
Requirements:
- In-depth knowledge 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.
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
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