Janani Mohan Email & Phone Number

St.Hubert Montreal

Chennai, Tamil Nadu, India

⦿ Collaborated with cross-functional teams including Quality Assurance (QA) and Quality Control (QC) to develop and maintain product configurations that adhere to FDA regulations and comply with ISO standards.⦿ Generated incident reports and worked with the relevant stakeholders to address and resolve any issues related to quality.⦿ Trained and provided a comprehensive training experience for new team members on product configuration processes, FDA regulations, and industry standards covering all aspects of the pharmaceutical industry⦿ Developed training materials and provide hands-on guidance to ensure that new team members are proficient in using software applications and adhering to regulatory requirements to contribute effectively to the team's goals and objectives.⦿ Managed user roles and access to software applications, ensuring that access is granted according to company policies.

Chennai, Tamil Nadu, India

⦿ Created and maintained product configuration settings for packaging, raw materials, finished product and stability to support product development and manufacturing processes as per latest and revised industry protocols.⦿ Ensured compliance with Standard Operating Procedures (SOPs) and other relevant regulatory requirements.⦿ Managed inventory of chemicals and equipment and ensured that they are updated and maintained appropriately.⦿ Participated in cross-functional teams to support continuous improvement initiatives and identify opportunities to streamline processes and improve quality.⦿ Ensured safety and security during audits by implementing appropriate measures to protect sensitive data and intellectual property. Maintained accurate and up-to-date records of all audit activities to facilitate compliance with regulatory requirements and provide a clear audit trail.