Able to perform Data Integrity compliance/impact assessments, risk assessments and create short executive summary reports.
Perform data analysis, identify trends and prepare metrics.
3-5 years of experience applying global data integrity regulations to cGMP operations, computer system validation, pharmaceutical manufacturing, lab testing, supply chain process, and quality management systems.
3-5 years of experience with Data Integrity risk assessments and process improvements in GxP operations.
Will undergo extensive training in DI.
We are seeking a quick learner who is willing to be hands-on for the long-term.
Experience in FDA regulated environment with strong understanding compliance issues as well as cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk-based validation and 21 CFR Part 11.
Strong organizational, communication (written and oral), and interpersonal skills. Team oriented, dependable, self-starter.
Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies.
Must have excellent communication skills, be organized and good at multi-tasking.