
Sterile Manufacturing Process Validator
3 days ago
Seeking a Quality Assurance Specialist to ensure the integrity of sterile injectable manufacturing processes.
Your key responsibilities will include:
- Validation Protocol Management: Prepare, review, and approve validation protocols and reports for media fill studies, area qualification, periodic requalification, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), cleaning validation, and process validation.
- Data Analysis and Reporting: Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions. Prepare and review environmental monitoring summaries and data for compliance with cGMP and regulatory requirements.
- Documentation and Communication: Maintain and update the Validation Master Plan (VMP) to ensure alignment with regulatory expectations and site needs. Communicate effectively with cross-functional teams and prioritize tasks.
To succeed in this role, you will need:
- Deep Knowledge: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise: Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP, etc.).
- Analytical Skills: Strong analytical and problem-solving skills.
- Effective Communication: Effective communication and documentation skills.
Educational Requirements:
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
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