Quality Assurance Specialist
4 weeks ago
Medivant Healthcare is a pioneer in the pharmaceutical industry, providing high-quality products reliably, efficiently, affordably, and at scale for hospitals, healthcare providers, and their patients.
Founded in 2015 and based in Phoenix, Arizona, Medivant Healthcare operates two fully automated CGMP FDA-registered facilities in Arizona, producing Single Dose liquid injectable vials and pre-filled syringes.
Responsibilities Manufacturing Oversight- Monitor and oversee sterile injectable manufacturing activities on the shop floor to ensure adherence to cGMP, SOPs, and regulatory requirements.
- Provide real-time guidance and decision-making during production to ensure product quality and compliance.
- Prepare, review, and approve Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) to ensure accurate documentation and compliance with manufacturing procedures.
- Ensure completeness, accuracy, and timely review of all manufacturing records.
- Perform in-process quality checks during manufacturing stages to ensure critical process parameters and product specifications are met.
- Review and verify product labels for accuracy, ensuring they meet regulatory standards and internal quality requirements.
- Document results and address deviations immediately to avoid process interruptions.
- Review and approve change control proposals.
- Assess the impact of changes on validation and regulatory compliance.
- Investigate deviations, identify root causes, and implement corrective actions.
- Document and trend deviations to monitor quality improvements.
- Develop and implement Corrective and Preventive Actions (CAPAs) for identified issues.
- Track and verify CAPA effectiveness within the specified timeline.
- Manage Out-of-Specification (OOS), Out-of-Trend (OOT), and conduct thorough investigations, and prepare investigation reports.
- Implement corrective actions to prevent recurrence.
- A valid B1/B2 Visa for the USA.
- Willingness to travel for work, including international travel to the USA and other regions as required.
- Ability to work according to US timings when working remotely.
- 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.
- Bachelor's or Master's degree in Pharmacy, Biotechnology, Microbiology, or a related field.
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