Job Description
Designation: Senior Research Officer
Location: Mahape, Navi Mumbai
Job Description:
The Senior Research Officer will be responsible for conducting advanced toxicological assessments in a dry lab environment, supporting regulatory compliance, and ensuring the safety and quality. The role involves risk assessment, impurity evaluation, dossier preparation, and implementation of contamination control strategies aligned with global regulatory expectations.
Key Responsibilities:
1. Evaluate toxicological literature, including in vivo/in vitro studies, to identify potential hazards, adverse effects, and dose-response relationships.
2. Conduct hazard identification, toxicological data reviews, and risk assessments to ensure compliance with EMA/FDA, ICH, and EHS regulations.
3. Develop and update Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports for APIs, ensuring safety for patients and cleaning validation
4. Establish Occupational Ex...
Location: Mahape, Navi Mumbai
Job Description:
The Senior Research Officer will be responsible for conducting advanced toxicological assessments in a dry lab environment, supporting regulatory compliance, and ensuring the safety and quality. The role involves risk assessment, impurity evaluation, dossier preparation, and implementation of contamination control strategies aligned with global regulatory expectations.
Key Responsibilities:
1. Evaluate toxicological literature, including in vivo/in vitro studies, to identify potential hazards, adverse effects, and dose-response relationships.
2. Conduct hazard identification, toxicological data reviews, and risk assessments to ensure compliance with EMA/FDA, ICH, and EHS regulations.
3. Develop and update Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports for APIs, ensuring safety for patients and cleaning validation
4. Establish Occupational Ex...