Overview
On Site
Full Time
Skills
Data Integrity
Functional Requirements
Risk Assessment
Scripting
IQ
OQ
PQ
Quality Management
Clinical Trials
SaaS
PaaS
IaaS
Software Testing
Test Cases
21 CFR Part 11
GAMP
Virtual Team
Quality Assurance
Communication
Microsoft Exchange
Forms
Software Engineering
Computer Science
Information Technology
Computerized System Validation
Pharmaceutics
Medical Devices
Clinical Research
Health Care
Testing
System Administration
Recovery
Auditing
Status Reports
Management
Job Details
Responsibilities:
- Participate on teams of internal resources in delivery of CSV projects.
- Author functional requirements specifications that are complete, accurate, and testable.
- Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments.
- Author Validation Plans and Validation Reports.
- Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices.
- Experience in validation at least two of these computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.
- Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem.
- Working knowledge of software testing techniques and test case development best practices.
- Working knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.
- Working knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
- Able to work effectively with local and virtual team members and other professionals, such as QA specialists, software developers, and system users.
- Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
- AS or B.S./B.A. in Software Engineering, Computer Science, Information Technology, or a related field.
- Minimum 2 years of experience in the field of Computer System Validation.
- Minimum 2 years of experience in Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.
- Execute validation and verification testing protocols and document results
- Author SOPs for User Operation, System Administration and Maintenance, Back-up/Recovery, and Audit Trail Review
- Prepare project status reports for clients and ProPharma management
- Extensive travel may be required at times.
- Other duties as assigned.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.