
Senior Validation Specialist
21 hours ago
We are seeking a seasoned Quality Assurance Specialist to join our team. This key role is responsible for ensuring the integrity of our manufacturing processes.
To be successful in this position, you will require a minimum of 10-15 years of experience analyzing remote media fill results and recommending corrective or preventive actions.
- Prepare and review validation protocols and reports for media fill studies to guarantee aseptic process integrity.
- Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
- Develop and review area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data.
- Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
- Support equipment qualification through Factory Acceptance Test (FAT) execution at vendor locations.
- Develop and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
- 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.
- Ability to manage cross-functional teams and prioritize tasks.
The ideal candidate will possess a Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
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