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QC-Micro QMS Specialist

1 month ago

Delhi, Delhi, India Medivant Healthcare Full time
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: QC-Microbiology (QMS)
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:
Quality Management System (QMS) Activities:
Oversee and perform all Quality Management System (QMS) activities for the Quality Control Microbiology department.
Conduct and review investigations related to microbiological laboratory OOS/OOT, environmental monitoring deviations, and sterility failures.
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 microbiological QC processes, ensuring alignment with regulatory and internal standards.
Microbiology Data Review:
Review and verify data from microbiological analysis for raw materials, in-process samples, finished products, and environmental monitoring.
Ensure data integrity and compliance with cGMP and regulatory standards.
Approve microbiological Certificates of Analysis (CoA) for final product release
Trend Analysis and Reporting:
Review and analyze quarterly trends for microbiological results, environmental monitoring, sterility tests, 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 microbiological methods are validated and meet required specifications.
Review and approve method validation and verification 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 microbiological analysis.
Ensure the accuracy and execution of environmental monitoring and sterility study protocols and reports.
Oversee the preparation and review of SOPs and protocols related to QMS activities
Environmental Monitoring and Sterility Oversight:
Monitor and oversee the execution of environmental monitoring and sterility programs.
Ensure environmental monitoring and sterility programs align with regulatory guidelines and product specifications
Audit Preparation and Compliance:
Prepare the Quality Control Microbiology 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 microbiology personnel on SOPs, regulatory guidelines, and good laboratory practices (GLP).
Assess and monitor the competency of microbiology analysts
Continuous Improvement Initiatives:
Lead initiatives to improve microbiological QC processes and enhance efficiency.
Participate in cross-functional teams to drive quality improvement projects
Regulatory Compliance and Documentation:
Lead initiatives to improve microbiological QC processes and enhance efficiency.
Ensure microbiological QC laboratory operations comply with cGMP, US FDA, and other regulatory requirements.
Maintain comprehensive and organized QC microbiology documentation, including laboratory notebooks, logbooks, and validation reports.
Prepare and review documentation to ensure regulatory compliance and accuracy
Key Skills and Competencies:
Lead initiatives to improve microbiological QC processes and enhance efficiency.
In-depth knowledge of Quality Control in sterile injectable microbiology processes.
Experience of laboratory oversight for microbiology 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 Science, Biotechnology, Microbiology, or related field.