Job Title:

QC & Training Manager

Business Unit:

MACR

Grade:

G10

Location:

Mumbai

YOUR TASKS AND RESPONSIBILITIES:

This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness.

This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures.

Systems and Processes:
- Develop, implement and maintain a Quality Management System (QMS)



for clinical trial team in consultation with Head – Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations.
- Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department.
- To assist in designing a process to write, review and approve the risk assessments for current trials and for ongoing projects and working closely with Project Managers and Operation Head as needed.
- To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness.
- Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements.
- Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management

📌 QC & Training Manager (India)
🏢 Sun Pharmaceutical
📍 India