13 Sep
|
Glaxosmithkline
|
Bengaluru
13 Sep
Glaxosmithkline
Bengaluru
Job Purpose
This role exists to:
Ensure Compliance and Product Quality: The role ensures that Periodic Product Reviews (PQRs) are conducted effectively and in compliance with approved procedures, regulatory requirements, and global quality standards to maintain product quality and safety.
Drive Process Efficiency and Improvement: The role supports the standardization, automation, and continuous improvement of the PQR process, fostering operational efficiency and alignment with organisational goals.
Provide Expert Support: The role contributes to the delivery of the MAH strategy, acts as a Subject Matter Expert (SME) for PQR processes, and provides insights and recommendations to the GBPO to drive informed decision-making and future improvements.
Key Responsibilities:
Describe the key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role.
Periodic Product Reviews (PQRs):
Manage and ensure the execution of PQRs for EU single schedules in alignment with approved procedures and timelines.
Oversee the preparation of PQR schedules based on product requirements and ensure adherence to the approved process.
Process Optimization:
Support the standardization and continuous improvement of the PQR process, driving efficiency and consistency.
Collaborate on automation initiatives for LOC PQRs to streamline workflows and enhance productivity.
Subject Matter Expertise:
Act as a Subject Matter Expert (SME) for PQRs, providing guidance and expertise to stakeholders.
Compliance Management:
Ensure compliance with all identified actions arising from Periodic Product Reviews.
Regularly update Standard Operating Procedures (SOPs) to align with relevant Global Quality Procedures (GQPs) and Global Quality Management Principles (GQMPs).
Performance Monitoring:
Share PQR status updates and recommendations during SQC (Site Quality Council) meetings, ensuring transparency and alignment.
Continuous Improvement: Identify and share ar
📌 Manager Pqr Gcc Bengaluru
🏢 Glaxosmithkline
📍 Bengaluru