Quality Control Manager-Stability

2 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Akums Drugs and Pharmaceuticals Ltd

time outline icon Haridwar, Uttarakhand, India

Posted on 09-01-2025

1 Vacancy

Description

Oversee and manage the company’s stability testing program, ensuring that all products undergo the appropriate stability studies as per regulatory requirements and internal standards.
Coordinate and manage stability testing across different phases of product development and lifecycle (e.g., accelerated, real-time, and long-term studies).
Ensure stability protocols and reports are developed and maintained in compliance with Good Manufacturing Practices (GMP), ICH guidelines, and regulatory requirements.
Develop and implement stability study plans, including timelines, protocols, and testing conditions.
Supervise the collection, analysis, and interpretation of stability data.
Ensure that stability data is properly documented, stored, and reviewed for accuracy and compliance with applicable regulatory standards.
Analyze trends in stability data and communicate findings to relevant departments
Lead and manage the stability team within the quality control department, providing guidance, support, and performance evaluations.
Ensure that all team members are adequately trained on stability testing procedures, regulatory guidelines, and company policies.
Foster a culture of continuous improvement, encouraging the team to implement best practices and optimize stability testing processes.