We Need a Candidate Currently Holding B1/B2 Visa of USA.About Company: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.Experience Required: 10-15 yearsLocation: Remote/On-siteDepartment: Quality Control (QMS)Salary: As per Market StandardNo. of vacancy: 01Mandatory Requirements:Valid B1/B2 Visa for the USA.Willingness to travel for work, including international travel to the USA and other regions as required.Have to work as per US timings when working remotely.Key Responsibility: Quality Management System (QMS) Activities:Oversee and perform all Quality Management System (QMS) activities for the Quality Control department.Conduct and review investigations related to laboratory incidents, out-of-specification (OOS), and out-of-trend (OOT) results.Identify root causes and recommend corrective and preventive actions (CAPAs).Ensure timely closure of laboratory deviations and maintain thorough documentation.Lead the preparation, review, and approval of QMS documentation, including change controls, risk assessments, and quality records.Perform and oversee the preparation and review of documentation related to QC processes, ensuring alignment with regulatory and internal standards.Analytical Data Review:Review and verify data from chemical analysis for raw materials, in-process samples, finished products, and stability studies.Ensure data integrity and compliance with cGMP and regulatory standards.Approve Certificates of Analysis (CoA) for final product release.Trend Analysis and Reporting:Review and analyze quarterly trends for chemical analysis, OOS results, and deviation reports.Collaborate with QC teams to implement corrective measures based on trend analysis.Method Transfer and Validation:Oversee method transfer activities between manufacturing sites or contract laboratories.Ensure analytical methods are validated and meet required specifications.Review and approve method validation reports.Standard Operating Procedures (SOPs) and Protocol Review:Review and approve laboratory SOPs to ensure compliance with regulatory guidelines and internal quality standards.Evaluate and approve method validation protocols and reports for chemical analysis.Ensure the accuracy and execution of stability study protocols and reports.Oversee the preparation and review of SOPs and protocols related to QMS activities.Stability Program Oversight:Monitor and oversee the execution of stability studies.Ensure stability programs align with regulatory guidelines and product specifications.Audit Preparation and Compliance:Prepare the Quality Control department for internal and external audits (US FDA, state FDA, customer audits, etc.).Conduct pre-audit checks to assess laboratory readiness and compliance.Address audit observations and ensure timely closure of identified gaps.Support regulatory inspections by providing necessary documentation and explanations.Training and Competency Assessment:Develop and conduct training programs for QC personnel on SOPs, regulatory guidelines, and good laboratory practices (GLP).Assess and monitor the competency of QC analysts.Continuous Improvement Initiatives:Lead initiatives to improve QC processes and enhance efficiency.Participate in cross-functional teams to drive quality improvement projects.Regulatory Compliance and Documentation:Ensure QC laboratory operations comply with cGMP, US FDA, and other regulatory requirements.Maintain comprehensive and organized QC documentation, including laboratory notebooks, logbooks, and validation reports.Prepare and review documentation to ensure regulatory compliance and accuracyKey Skills and Competencies:In-depth knowledge of Quality Control in sterile injectable manufacturing processes.Experience of laboratory oversight for chemical analysis.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, Science, Biotechnology, Microbiology, or related field.
Job Title
Quality Control (QC) QMS Specialist – Sterile Injectables