Job Title: QMS and Training Coordinator – Assistant Manager (Remote)Location: 100% Remote (Work from home)Experience Required: 8-12 yearsDepartment: Quality AssuranceNo. of vacancy: 01Company’s Overview: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, that produce Single Dose liquid injectable vials and pre-filled syringes.Key Responsibility: Training: Develop and deliver remote training programs on QMS processes and compliance.Training Tracking: Maintain digital training matrix, track progress, and ensure timely completion.Cross-Functional SOP Review: Review and update cross-functional SOPs to ensure alignment with QMS requirements.Master Control Uploading: Upload examinations, training records, and documentation in Master Control software.Job Code Creation: Create job codes and employee profiles in Master Control software for training management.Training Documentation: Ensure all training records are properly documented, stored, and tracked in Master Control.Change Control: Oversee the change control process and review documentation remotely.Deviation and CAPA: Manage deviation investigations and implement CAPA actions.Process Validation Protocols: Develop process validation protocols and review documentation.Validation Reports: Review and approve process validation reports to ensure regulatory compliance.APQR Preparation: Coordinate remotely the preparation of Annual Product Quality Review (APQR).APQR Data Review: Review APQRs, ensuring completeness, accuracy, and regulatory compliance.Data Analysis: Analyze product performance data and provide recommendations for improvement.Regulatory Knowledge: In-depth knowledge of cGMP, FDA, EMA, and global regulatory standards.Key Skills and Competencies: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. Education and Qualifications:Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.
Job Title
QMS and Training Coordinator – Assistant Manager (Remote)