Job Summary
We are looking for an individual for the Quality Assurance team to review and revise SOPs, oversee document control in product development, and conduct risk assessments. Responsibilities include reviewing specifications and STPs, ensuring data integrity, proposing QbD (Quality by Design) process changes, and participating in phase gate reviews.

Roles & Responsibilities
• You will be responsible for reviewing and revising SOPs (Standard Operating Procedures), obtaining supervisor approval for system-related revisions, and communicating SOP changes to product development teams.
• Your role involves the preparation, review, approval, and control of documents generated during product development.
• You will conduct, review, and approve risk assessments throughout the product development process.
• You will review and approve specifications and Standard Testing Protocols (STPs) for various materials at different development stages, ensuring compliance with guidelines and SOPs during all stages of development and technology transfer.
• Your responsibilities include exercising control over data integrity, checking documentation and product development reports related to filings, and participating in proposing Quality by Design (QbD) process changes.
• You will also conduct, review, and approve phase gates for drug products in coordination with development, and conduct self-inspections at the Integrated Product Development Organization (IPDO) according to the schedule.
• You will be responsible for ensuring compliance in development laboratories, reviewing and approving facility/equipment qualifications at IPDO, and managing Quality notifications such as incidents and change controls through the Quality management system.