dears, we're in a need for a freelancer with the below skills, and to take responsibility of the below tasks, for an API Pharmaceutical plant project :
1. Responsible to conduct Computer System Validation (CSV) in compliance with current US and EU regulatory guideline.
2. Familiar with 21 Code of Federal Regulations (CFR) Part 11 , GAMP 5 for Software / Hardware Categories and EMEA, EudraLex —Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use: Annex 11—Computerized Systems"
3. Implement the validation strategy based on computerized system lifecycle, Risk Based validation activity, Categorization of system as per GAMP.
4. Responsible to validate computerized system like Process control system, BMS System, DCS / SCADA / PLC based system, Database system including ERP such as SAP & LIMS.
5. Responsible for development of validation philosophy and developing the qualification protocol (DQ,IQ,OQ and PQ) as per current regulatory guideline.
6. Performing a Vendor assessment
7. Preparation of user requirements Specifications (URS).
8. Resolve technical and tactical operational problems within the scope.
9. Educate Plant, QA and all technical functions in CSV and GAMP5 requirements and develop and maintain CSV SOPs to meet regional and GAMP5 requirements.
10. Lead and / or participate as a CSV Subject Matter Expert for all FDA, Corporate or other regulatory inspections.
11. Routine audit of validated systems and implement corrective actions as necessary.
12. Gap analysis for existing systems
13. Maintain the computerized System inventory of qualified computerized direct impact systems it contains
14. Any change (even a small change) is made to the software, the validation status of the software needs to be re-established
15. Activities in a typical software life cycle model include from Project phase, Operational phase and system retirement phase.