Regulatory & Quality Manager

The Regulatory and Quality Manager role in Noida requires a female candidate and involves various responsibilities related to quality management and regulatory compliance. You will be responsible for implementing the Quality Management System in alignment with regulatory requirements. This includes managing regulatory documentation and overseeing the Continual Improvement of Systems, Product Quality Review Process, Corrective and Preventive Action System. Your accountability extends to ensuring data integrity and implementing SOPs and policies. You will evaluate and approve master documents across different departments and prepare and approve various master documents such as BMR, SOP, STP, SPEC, formats, and checklists. Additionally, you will manage Control Sample and Stability Management, implement QA systems for compliance with SOPs, and handle both external and internal audits. You will review, evaluate, and approve documents on behalf of the factory department under the guidance of the technical head. As part of your responsibilities, you are expected to adhere to cGMP practices and ensure the proper implementation of recorded information. Furthermore, you will review and approve equipment qualification/requalification/validation protocols and compile summary reports of the products. If you are interested in this position, please send your application to pharmahr@bjainpharma.com.,