
Sterile Manufacturing Validation Specialist
4 days ago
About the Role:
Main Responsibilities:
Ensure aseptic process integrity by conducting thorough validation activities for sterile injectable manufacturing processes.
Prepare and review protocols and reports for media fill studies, area qualification, periodic requalification, installation qualification, operational qualification, performance qualification, and cleaning validation.
Analyze remote media fill results to identify deficiencies and recommend corrective or preventive actions.
Support and participate in Factory Acceptance Test (FAT) execution at vendor locations, ensuring test protocols are followed and results are documented.
Key Qualifications:
Deep understanding of sterile injectable manufacturing processes and aseptic techniques.
Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP).
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.
Candidate Profile:
Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
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