Sr. Executive RQA

2 - 7 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Synokem Pharmaceuticals Ltd

time outline icon Haridwar, Uttarakhand, India

Posted on 06-12-2023

18 Views

1 Vacancy

Description

Regulatory Compliance: Officers in Regulatory and Quality Assurance are responsible for ensuring that products and processes comply with applicable regulations and standards. This includes staying informed about regulatory changes, interpreting requirements, and guiding the organization in maintaining compliance.
Quality Management System (QMS): RQA professionals contribute to the development, implementation, and maintenance of the Quality Management System. They help establish quality policies, procedures, and documentation to ensure that products meet regulatory requirements and quality standards.
Audit Preparation and Support: RQA officers assist in preparing for internal and external audits, including regulatory inspections. They conduct internal audits to assess compliance with established quality systems and assist in addressing audit findings, corrective actions, and preventive actions to enhance overall quality.
Documentation and Reporting: Officers in RQA maintain detailed records related to regulatory compliance, quality metrics, and audit activities. They prepare reports summarizing quality performance, regulatory submissions, and any corrective actions taken to address non-compliance or quality issues.
Communication with Regulatory Authorities: RQA professionals serve as a liaison between the organization and regulatory authorities. They prepare and submit regulatory documents, respond to inquiries, and facilitate communication to ensure that the company's products and processes align with regulatory expectations and requirements.