- Document Review & Approval: QA reviews and signs off on User Requirement Specifications (URS), Validation Master Plans (VMP), and specific protocols/reports (IQ/OQ/PQ) before clinical or commercial use.
- Equipment Qualification: Ensures that manufacturing and laboratory equipment is properly installed, operates within specified limits, and consistently performs as intended.
- Process & Cleaning Validation: Confirms that manufacturing processes consistently yield products meeting quality specifications. QA verifies that cleaning procedures effectively remove contaminants and prevent cross-contamination.
- Computer System Validation (CSV): Validates software, automated equipment, and IT systems used in manufacturing or data management to ensure functional reliability and data integrity.
- Analytical Method Validation: Approves data proving that laboratory testing methods are accurate, precise, and reliable for quality control.
- Change Control Management: Acts as a Subject Matter Expert (SME) to evaluate and authorize changes to validated systems, assessing potential impacts on product quality.
Pay: ₹20,000.00 - ₹28,000.00 per month
Benefits:
- Flexible schedule
- Food provided
- Health insurance
- Life insurance
- Provident Fund
Education:
Experience:
- validation: 3 years (Required)
Work Location: In person
