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GSK India
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Specialist-PQR-GCC

Specialist-PQR-GCC

GSK India

5 - 10 years

11 - 13 Lacs

bengaluru

Posted:19 hours ago| Platform:

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Skills Required

procurement business process product quality automation process optimization pharmacy oncology life sciences continuous improvement operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Purpose

This role exists to:

Ensure Compliance and Product Quality: The role ensures that Periodic Product Quality 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:

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 areas for improvement as a result of comprehensive product reviews, fostering a culture of innovation and growth.

Knowledge/ Education / Experience Required:

Bachelors degree in a relevant field (e.g., Pharmacy, Life Sciences, Quality Management).
5+yrs of experience of pharmaceutical quality assurance / regulatory and distribution / manufacturing.
Experience in a business process role in a complex global organization.

Why GSK

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK India

Pharmaceuticals & Biotechnology

Mumbai

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Specialist-PQR-GCC