Pharma Data Integrity / Data Analysis / Data Compliance Analyst - Remote
Long term (multi-year) contract with client based in Foster City, CA
THIS ROLE IS 100% REMOTE
MUST HAVE PHARMA EXPERIENCE!
Consultant must have the following:
- Very good with data analysis, identifying trends and preparing metrics.
- Very good presentation skills - A good storyteller
- Need to have strong critical, analytical/ logical thinking skills.
- Familiar with using Office 365 suite of applications. (Powerpoint, Excel, etc.)
- Perform "Data Integrity" related- risk assessments, Deviation investigations, suggest ,implement remediations in cGMP operations.
- 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.