Offer summary
Qualifications:
5+ years of business analysis experience, preferably in the pharmaceutical industry, Strong knowledge of computer systems validation and regulations like 21 CFR Parts 11 and 203, Bachelor's Degree from a 4-year accredited institution, Experience with Prescription Drug Marketing Act (PDMA) is required.
Key responsabilities:
- Transform and maintain design documents into functional requirements with Product Management
- Ensure quality and timely validation processes of requirements for system solutions
- Aid in evaluating and prioritizing risks for validation testing procedures
- Communicate requirements effectively for compliance and validation outputs