Job Description
- Execute aseptic process simulations (APS) and support process validation activities, including documentation, execution, and result review.
- Develop and author validation protocols such as URS, IQ, OQ, and PQ in alignment with GDP and GMP standards.
- Perform equipment and analytical instrument qualification following regulatory and internal guidelines.
- Conduct automation and software compliance assessments to ensure adherence to 21 CFR Part 11 requirements.
- Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete CQV (Commissioning, Qualification & Validation) tasks.
- Support validation of automated manufacturing systems and sterile process controls.
- Maintain accurate, audit-ready validation documentation in compliance with quality system requirements.
- Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek.
- Ensure all work aligns with applicable SOPs, regulations, and Good Documentation Practices (GDP).