JOB SUMMARY

We are seeking a detail-oriented professional to provide services as QA CSV Consultant.

• Participate in all qualification implementation of computerized and noncomputerized systems following the proper life cycle phases of a project.
• Ensure all requirements are properly traced, tested, and qualified across the life cycle of the project.
• Review and approve various project documentation including URS, FRS, HDS, and testing protocols.
• Evaluate and determine the potential impact of process changes of products quality/cost.
• Evaluate, review and approve all plant CSV life cycle documentation and test results for compliance with regulatory standards.
• Develop procedures and qualification documentations related to Computarized Systems and Validation.
• Collaborating with cross-functional teams to ensure validation activities meet quality standards and adhering to internal policies and SOPs.
  Experience
  Bachelor’s degree in scientific or engineering discipline.
  Minimum of 6 years of experience in computer system validation within the pharmaceutical or biotech industry and knowledge in compliance of Computerized Systems and its Software Development Life Cycle (SDLC), qualification of facilities, Utilities, Equipment and Laboratory Automated Laboratory Practices (GALP)
  Must have at least 3 years’ experience as QA Validation in implementation of facilities, equipment and systems in the area of Room Alarm Monitoring, HVAC, Water/Cleaning Systems. Review and approval of all the qualification and CSV life cycle documentation, test results and compliance with good software engineering practices and regulatory standards.
  Job Type: Contract
  Work Location: In perso