QC-Micro QMS Specialist (Sterile Injectables)

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:

• 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

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 Skills and Competencies:

• 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.