Title: Data Integrity / Validation Analyst
Type of role: Contract 12++ months
Location: Foster City, CA 94404 (*Remote during COVID)
Perform “Data Integrity” risk assessments, Deviation investigations, write summary reports, suggest remediations in cGMP operations. For this, a consultant need to have an understanding of current global regulatory expectations around data integrity, computer system validation, pharmaceutical manufacturing, lab testing, supply chain process, and quality management systems.
Able to create data process maps and perform risk assessments (failure mode analysis).
Able to perform compliance gap assessments, risk assessments and create summary reports.
Candidate must have experience with Data Integrity related assessments and process improvements in GxP operations.
Good with systems analysis, excellent oral and written communication skills.
Ability to think through the task
Fast learner with multiple technologies used in cGMP operations
Thorough understanding of the principles of computer systems validation, SDLC, VLC methodologies.
Extensive Knowledge of applying 21CFR Part11, 211, Annex 11, and industry best practices into operations.
Need to have strong critical/analytical/logical thinking skills.
Need to have good presentation skills. (A good storyteller)
Ability to work independently without supervision.