Auftragsdetails

Essential Functions Include:

• Leading computer system users in documentation of user requirements
• Authoring functional requirements specifications that are complete, accurate, and testable
• Authoring system Risk Assessments, 21 CFR 11 and Annex 11 Assessments
• Authoring Validation Plans and Validation Reports
• Authoring validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices
• Executing validation and verification testing protocols and documenting results
• Authoring SOPs for User Operation, System Administration and Maintenance, Back-up/Recovery, and Audit Trail Review
• Preparing status reports for client and ProPharma Group management
• Validation of SaaS and COTS applications used within the pharmaceutical and medical device industries, such as applications for QMS (e.g., TrackWise, MasterControl), DMS (e.g., Veeva, Documentum), ERPs (e.g., SAP, JD Edwards), MES (Delta V), EDC (e.g., Medidata), CTMS (e.g., Impact, Oracle Clinical), LIMS (e.g., LabWare, Darwin), Lab Software (e.g., Empower, ChemStation, NuGenesis), PV (Argus, Empirica Signal)

Qualified candidates must have:

• 3 or more years of computer system validation experience for CSV Engineer
• Experience in validation of Clinical systems (e.g., eTMF, EDC, CTMS) and at least one other software application category (either QMS, DMS, ERP, Lab, Manufacturing)
• Knowledge of FDA GxP (21 CFR 50, 58, 210, 211, 312, 314, 600, 606, 820) requirements, 21 CFR Part 11, FDA software validation guidelines, EU Annex 11, and GAMP V
• Knowledge of software testing techniques and expertise in test case development
• Strong analytical skills, attention to detail, and passion for quality
• Able to organize and perform own work tasks independently
• Able to work effectively with local and virtual team members and other professionals, such as QA specialists, software developers, and system users.
• Proficiency with Microsoft applications, including Word and Excel
• Bachelor’s degree in Computer Science, Software Engineering or a scientific or healthcare discipline

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties.  Please, no phone calls or emails to anyone regarding this posting.***