Junior Associate

1.
Supervise QMS tracking activities, including OOS, CAPAs, Deviations, and Change Controls, ensuring timely closure and compliance with regulatory timelines.
2.
Manage laboratory operations, ensuring proper calibration, maintenance, and compliance of laboratory equipment and documentation.
3.
Oversee investigation reports for QMS elements, ensuring root cause analysis, corrective actions, and preventive measures are properly documented before submission to QA.
4.
Ensure audit readiness by consolidating and organizing all QMS-related documentation, preparing the lab for internal and external regulatory inspections.
5.
Coordinate and mentor QCM analysts, ensuring proper training, knowledge sharing, and compliance with QMS best practices.
QMS Tracking & Compliance Monitoring:

•
Supervise and ensure the timely closure of all QMS-related elements (OOS, CAPAs, Deviations, Change Controls) raised by QCM.

•
Conduct weekly compliance tracking reports, detailing overdue QMS elements and identifying risks for escalation.

•
Ensure 100% closure of all QMS-related actions within stipulated compliance deadlines, preventing compliance risks and audit non-conformances.

•
Act as the primary liaison with QA and regulatory teams, ensuring timely follow-ups on CAPA effectiveness reviews and compliance updates.

•
Lead cross-functional discussions to align Change Control activities with facility-wide QMS objectives.

•
Ensure timely execution of Change Control action plans, tracking completion status and escalating delays where necessary.
Investigation & Documentation Review:

•
Review and approve all investigation reports for OOS, CAPAs, and Deviations before submission to QA.

•
Ensure root cause analysis and corrective/preventive action plans (CAPA) are well-documented and aligned with regulatory expectations.

•
Oversee data integrity for investigation reports, ensuring compliance with cGMP, GDP, and regulatory documentation standards.

•
Conduct internal reviews of deviation reports to verify documentation completeness and accuracy before submission.
Laboratory Operations Management:

•
Oversee and ensure proper calibration, maintenance, and validation schedules for all microbiology laboratory equipment.

•
Maintain and track logbooks, qualification records, and instrument calibration schedules in compliance with QMS.

•
Ensure the proper handling and organization of QMS records and laboratory documentation, avoiding discrepancies during audits.

•
Act as Administrator for software-connected laboratory equipment, ensuring authorized personnel access and data integrity.

•
Review and approve laboratory validation protocols, ensuring execution aligns with quality and regulatory standards.
Documentation & Audit Readiness:

•
Ensure QMS documentation is audit-ready at all times, consolidating compliance data for internal and external regulatory audits.

•
Coordinate regulatory audit preparation, ensuring CAPA actions are implemented and compliance risks are mitigated.

•
Support QA and regulatory teams by tracking audit findings, following up on action items, and implementing compliance improvements.

•
Ensure that 100% of QMS action items from audits are completed within regulatory timelines.
Team Leadership & Development:

•
Ensure 100% training compliance for QMS tracking personnel, maintaining up-to-date training records.

•
Mentor QCM team members, providing guidance on QMS compliance best practices and document management

1.
Supervise QMS tracking activities, including OOS, CAPAs, Deviations, and Change Controls, ensuring timely closure and compliance with regulatory timelines.
2.
Manage laboratory operations, ensuring proper calibration, maintenance, and compliance of laboratory equipment and documentation.
3.
Oversee investigation reports for QMS elements, ensuring root cause analysis, corrective actions, and preventive measures are properly documented before submission to QA.
4.
Ensure audit readiness by consolidating and organizing all QMS-related documentation, preparing the lab for internal and external regulatory inspections.
5.
Coordinate and mentor QCM analysts, ensuring proper training, knowledge sharing, and compliance with QMS best practices.
QMS Tracking & Compliance Monitoring:

•
Supervise and ensure the timely closure of all QMS-related elements (OOS, CAPAs, Deviations, Change Controls) raised by QCM.

•
Conduct weekly compliance tracking reports, detailing overdue QMS elements and identifying risks for escalation.

•
Ensure 100% closure of all QMS-related actions within stipulated compliance deadlines, preventing compliance risks and audit non-conformances.

•
Act as the primary liaison with QA and regulatory teams, ensuring timely follow-ups on CAPA effectiveness reviews and compliance updates.

•
Lead cross-functional discussions to align Change Control activities with facility-wide QMS objectives.

•
Ensure timely execution of Change Control action plans, tracking completion status and escalating delays where necessary.
Investigation & Documentation Review:

•
Review and approve all investigation reports for OOS, CAPAs, and Deviations before submission to QA.

•
Ensure root cause analysis and corrective/preventive action plans (CAPA) are well-documented and aligned with regulatory expectations.

•
Oversee data integrity for investigation reports, ensuring compliance with cGMP, GDP, and regulatory documentation standards.

•
Conduct internal reviews of deviation reports to verify documentation completeness and accuracy before submission.
Laboratory Operations Management:

•
Oversee and ensure proper calibration, maintenance, and validation schedules for all microbiology laboratory equipment.

•
Maintain and track logbooks, qualification records, and instrument calibration schedules in compliance with QMS.

•
Ensure the proper handling and organization of QMS records and laboratory documentation, avoiding discrepancies during audits.

•
Act as Administrator for software-connected laboratory equipment, ensuring authorized personnel access and data integrity.

•
Review and approve laboratory validation protocols, ensuring execution aligns with quality and regulatory standards.
Documentation & Audit Readiness:

•
Ensure QMS documentation is audit-ready at all times, consolidating compliance data for internal and external regulatory audits.

•
Coordinate regulatory audit preparation, ensuring CAPA actions are implemented and compliance risks are mitigated.

•
Support QA and regulatory teams by tracking audit findings, following up on action items, and implementing compliance improvements.

•
Ensure that 100% of QMS action items from audits are completed within regulatory timelines.
Team Leadership & Development:

•
Ensure 100% training compliance for QMS tracking personnel, maintaining up-to-date training records.

•
Mentor QCM team members, providing guidance on QMS compliance best practices and document management

Required Education Qualification: B.Sc (Hons)

Required Experience: 1 - 3 years