Team Member - Quality Assurance (Validation)

Job Summary
We are seeking an individual for the Quality Assurance team, responsible for overseeing various quality assurance activities to ensure compliance with regulatory requirements and maintain product quality. Your responsibilities will include managing change notifications, conducting investigations, handling market complaints, coordinating audits, and supporting regulatory filings.

Roles & Responsibilities

• Review of Technology transfer documents, Review of process and cleaning trial and validation documents, nitrosamine impurity assessments, CPV reports, batch production records and cleaning records etc.
• Reviewing and approving Quality Risk Management processes to identify, assess, and mitigate risks to product quality and patient safety.
• Performing SAP activities and updating Bills of Materials (BOM) and recipes accurately to reflect product specifications and changes.
• Monitoring plant activities related to trial and Validations. 
• Supporting marketing queries and DMF filings.
• Ensuring compliance with good manufacturing practice, GxP, and other regulatory requirements through self-training and adherence to established procedures.