
Sterile Process Specialist
3 days ago
**Job Title:** Quality Assurance Specialist
**Key Responsibilities:- Develop, review, and approve validation protocols and reports to ensure aseptic process integrity.
- Analyze media fill results, identify deficiencies, and recommend corrective actions.
- Prepare area qualification protocols and reports for manufacturing areas based on environmental monitoring data.
- Prepare periodic requalification protocols and reports for compliance with regulatory requirements.
- Develop Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
- Support Factory Acceptance Test (FAT) execution for equipment at vendor locations.
- Prepare utility qualification documentation, including HVAC and water system validation.
- Develop cleaning validation protocols and reports to ensure adequacy and suitability.
- Develop process validation protocols and reports to confirm process robustness.
- Maintain the Validation Master Plan (VMP) ensuring alignment with regulatory expectations.
- In-depth knowledge of sterile injectable manufacturing processes.
- Expertise in validation methodologies and regulatory guidelines.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams.
- Proficiency in QMS tools.
A bachelor's degree in Pharmacy, Biotechnology, Microbiology, or a related field is required.
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