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16 hours ago
We seek a highly experienced quality assurance specialist to ensure the quality and integrity of manufacturing processes.
- Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity.
- Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
- Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
- Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
- Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
- Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
- Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
- Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
- Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
- Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.
- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
- Proficiency in QMS tools and software.
Education: Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
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