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Sterile Manufacturing Validation Specialist
3 weeks ago
Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity.
As a key member of our team, you will analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions. This includes preparing and reviewing area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.
You will also prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements. In addition, you will prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
Furthermore, you will support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations. You will also prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
Finally, you will prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover. Additionally, you will prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
Required Skills and Qualifications:- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques is essential.
- Expertise in validation methodologies and regulatory guidelines is required.
- Strong analytical and problem-solving skills are necessary.
- Effective communication and documentation skills are required.
- Ability to manage cross-functional teams and prioritize tasks is expected.
- Proficiency in QMS tools and software is preferred.
- A Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field is required.
10-15 years of experience in Quality Assurance, preferably in sterile injectable manufacturing, is necessary.
