
QA Specialist
5 days ago
Job Title: QA Validator
Key Responsibilities:
- Develop and review validation protocols and reports to ensure aseptic process integrity.
- Analyze remote media fill results, identify deficiencies, and recommend corrective actions.
- Prepare and review qualification protocols and reports for manufacturing areas based on environmental monitoring data.
- Prepare and review periodic requalification protocols, data, and environmental summaries for compliance with regulatory requirements.
- Support equipment qualification execution at vendor locations, ensuring test protocols are followed and results documented.
- Prepare and review utility qualification documentation, including HVAC and compressed air system validation.
- Ensure cleaning validation adequacy and suitability for product changeover.
- Maintain the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.
Requirements:
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
- Expertise in sterile injectable manufacturing processes and aseptic techniques.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
- Proficiency in quality management systems.
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