Job Description

Our client requires a CSV Consultant to perform and manage the qualification of PV-Works. PV-Works by Ennov is a pharmacovigilance application used to collect adverse events for reporting. The CSV Consultant will manage the validation and assist in the development of system validation documentation. All deliverables will be routed and approved in an electronic document management system. All work is expected to be performed remotely and requires routine virtual meetings to maintain progress. The specific deliverables for this project include the following:

• Manage the validation of PV-Works
• Attend routine project meetings
• Report project status on a weekly basis
• Develop and route change control documentation
• Review and approve MCC
• Create and route FTP
• Review and approval of ALM test
• Update trace matrix
• Review configuration specs as needed
• Validation test review and approval
• Trace matrix approval
• DIL support
• FTR creation with DIL and MCC
• TAP administrative review and approval
• CCR creation and approval
• Support document routing and approval processes using the clients system
• Develop required validation documentation, consistent with internal client policies and
• procedures including LEVA requirements

Qualifications

Qualified candidates must have:

• B.S./B.A. in Engineering, Science, Information Technology or related field.
• Three years of relevant work experience may be substituted in lieu of education.
• Minimum 5-year experience in the field of Computer System Validation.
• Minimum 1-year experience in related Pharmaceutical or Healthcare Industries.
• Experience in the validation of at least one computer system category: automation control, laboratory systems, quality workflow, ERP, clinical data.
• Possess 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.
• General business math skills.
• Working knowledge of Microsoft Word, Microsoft Excel, and other word processing programs as may be required by the position (PowerPoint, Access and Microsoft Project may be required) including but not limited to Visio.
• Ability to walk, stand and move about for long periods of time; work with equipment in the field, read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.
• Basic knowledge of FDA GxPs, FDA Guidelines, and European Guidelines (where applicable) and other regulatory requirements.
• Basic knowledge of industry best practice such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
• Basic knowledge of 21 CFR 11, including ERES, predicate rule and legacy system requirements.

Additional Information

• All candidates must be legally eligible to work in the United States. 
• We are an equal opportunity employer. M/F/D/V
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.