Experience:2-5 years
Contract Role:6 Months
The
Computerized Quality Assurance (CQA) Validation Specialist is responsible for ensuring that computerized systems used in
API manufacturing facilities comply with applicable regulatory requirements and internal quality standards.
Knowledge on how to conduct validation of systems used in
API plants, such as:
- Distributed Control Systems (DCS)
- SCADA systems
- PLC-based equipment
- LIMS
- QMS
- ERP systems
Review And Approve Validation Documentation Including
- User Requirement Specification (URS)
- Functional Specification (FS)
- Design Specification (DS)
- Risk Assessment
- Validation Plan
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Traceability Matrix (RTM)
Skills
- Validation document review and approval
- Risk-based validation approach
- Audit and regulatory inspection support
- Strong documentation and compliance mindset
Education: Pharmacy / Chemical Engineering / Biotechnology
