
Sterile Product Validator
6 days ago
We are seeking an experienced Quality Assurance Specialist to ensure the quality and integrity of our products through thorough validation activities, analysis of results, and identification of corrective or preventive actions.
The ideal candidate will possess in-depth knowledge of sterile injectable manufacturing processes, aseptic techniques, and regulatory guidelines (US FDA, cGMP etc.).
This is a challenging role that offers the opportunity to work with a talented team of professionals and make a significant contribution to product quality.
- Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity.
- Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
- Prepare and review area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.
- Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
- Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
- Support Factory Acceptance Test (FAT) execution for equipment at vendor locations, ensuring test protocols are followed and results are documented.
- Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
- Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
- Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
- Maintain and update 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.
- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
- 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.
This role presents opportunities to enhance product quality and contribute to the company's success.
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