02 Oct
|
Tuv Sud South Asia PrivateLimited
|
Bengaluru
02 Oct
Tuv Sud South Asia PrivateLimited
Bengaluru
Job Title: Test Facility Manager (TFM)
Location: Bangalore
Reporting To: Head of MHS
Employment Type: Full-Time
Key Responsibilities
GLP Compliance & Regulatory Oversight
- Ensure the testing facility operates in full compliance with OECD GLP Principles and applicable national regulatory requirements.
- Establish, implement, and maintain organizational structures, procedures, and resources necessary to conduct GLP studies.
- Ensure that approved Standard Operating Procedures (SOPs) are available, implemented, and periodically reviewed.
- Oversee readiness for regulatory inspections, facility audits, and GLP monitoring authority assessments.
- Ensure corrective and preventive actions (CAPA) are effectively implemented and monitored.
Facility Management
- Manage day-to-day operations of the testing facility, including laboratories, animal facilities (if applicable), archives, stores, and support services.
- Ensure adequate infrastructure, utilities, environmental controls, and maintenance programs are in place.
- Oversee calibration, qualification, validation,
and maintenance of laboratory equipment and computerized systems.
- Ensure adequate staffing and competency levels across all facility functions.
Study Management Support
- Ensure qualified personnel are available for conduct of studies.
- Verify that Study Directors have the necessary resources to perform studies in compliance with GLP requirements.
- Facilitate communication among Study Directors, Principal Investigators, QA personnel, and laboratory staff.
- Monitor laboratory capacity, resource planning, and study scheduling.
Quality Assurance & Risk Management
- Support and promote a robust quality culture throughout the organization.
- Ensure an independent Quality Assurance Unit (QAU) is established and adequately resourced.
- Review quality trends, audit findings, deviations, and CAPA effectiveness.
- Lead risk assessments and continuous improvement initiatives.
Personnel Leadership & Developmen
📌 Test Facility Manager (Bengaluru)
🏢 Tuv Sud South Asia PrivateLimited
📍 Bengaluru