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 years
Location : Remote / On-site
Department : Quality Assurance (Laboratory)
Salary : As per Market Standard
No. of vacancy : 01
Mandatory 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 :
Analytical Data Review
- Review and verify data from chemical and microbiological 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
Quality Management System :
Conduct and review investigations related to laboratory incidents, out-of-specification (OOS), and out-of-trend (OOT) resultsIdentify root causes and recommend corrective and preventive actions (CAPAs)Oversee the closure of laboratory deviations and ensure effective documentationTrend Analysis and Reporting :
Review and analyze quarterly trends for environmental monitoring (EM), personnel monitoring, and OOS resultsCollaborate with microbiology and analytical teams to implement corrective measures based on trend analysisMethod Transfer and Validation :
Oversee method transfer activities between manufacturing sites or contract laboratories.Ensure analytical methods are validated and suitable for intended use.Review and approve method validation reports.Environmental and Personnel Monitoring Oversight :
Review and evaluate environmental and personnel monitoring data to ensure the sterility of manufacturing environments.Implement corrective measures when trends indicate potential contamination risks.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 and microbiological analysis.Review stability study protocols and reports to ensure accurate design and execution.Stability Program Oversight :
Monitor the execution of stability studies and review stability data.Ensure stability programs align with regulatory guidelines and product specifications.Audit Preparation and Compliance :
Prepare the laboratory for internal and external audits (US FDA, state FDA, customer audit 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 laboratory personnel on SOPs, regulatory guidelines, and good laboratory practices (GLP).Assess and monitor the competency of laboratory analysts.Continuous Improvement Initiatives :
Lead initiatives to improve laboratory processes and enhance efficiency.Participate in cross-functional teams to drive quality improvement projects.Regulatory Compliance and Documentation :
Ensure laboratory operations comply with cGMP, US FDA and other regulatory requirements.Maintain comprehensive and organized laboratory documentation, including laboratory notebooks, logbooks, and validation reports.Key Skills and Competencies :
In-depth knowledge of Quality Control in sterile injectable manufacturing processes.Experience of laboratory oversight for chemical and microbiology.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.