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.

- Robust 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.

📌 QC-Micro QMS Specialist (Sterile Injectables) (Ahmedabad)
🏢 Medivant Healthcare
📍 Ahmedabad