Computer Validation Specialist

Pharmaplan North America, Inc. seeks a highly motivated & experienced Computer Validation Specialist to join its North Carolina team. Candidate will implement & ensure the regulatory compliance of a Computer Validation program based on a specific computer validation philosophy. This person will also test cross-site functionality and computer validation support for database applications.

Key responsibilities include:
Develop, coordinate and execute computer system validation protocols for application systems that are governed by federal regulations, including 21 CFR Parts 210 and 211 with emphasis on 21 CFR Part 11 as applicable in the pharmaceutical industry.
Provide input to functional department personnel whom may also assist in writing protocols.
Write and execute validation protocols across sites.
Document, test and validate changes made to validated systems.
Perform gap analysis and Part 11 compliance audits for existing (legacy) and future systems/software and document findings in Summary Report.
Define root cause and corrective actions with assistance from site coordinators or superiors.
Maintain protocols in an orderly library so that information can be provided to regulatory bodies in a timely manner.
REQUIREMENTS
Knowledge of/expertise in the following:
oComputer System Validation.
oSpreadsheet and Access Database validation.
oExecuting IQ/OQ/PQ protocols.
oDiplomatic skills to interface with IT, Functional Group and QA.
oWriting master validation plan, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols and task report writing as it applies to computer systems validation.
oClient/server applications.
oRDMS Database (SQL server, etc.) applications.
oDocument Management Systems.
oChromatography Data System (CDS).
oMRP/MRPII/ERP.
oPLC/SCADA.
oData acquisition systems.
Excellent writing skills to prepare protocols, reports, summary documents, and equipment specifications.
Bachelor’s (BS) degree in technical field with GxP training.
Four to six years’ proven experience in computer systems validation, with particular knowledge of regulated biotechnology or drug computer system validation requirements, FDA 21 CFR Part 11, GAMP4 and experience with PLC and ERP computerized systems.
Excellent written and verbal communication skills.
Ability to work with IT hardware equipment, network, operating and application systems.
Knowledge of client/server technology and experience with manufacturing process, process controlled applications, Programmable Logic Controllers (PLC), knowledge of FDA regulations (cGMP) and Standard Operating Procedures (SOPs).
Previous experience in testing hardware, network and computer applications for business within FDA regulated industries (AS400, MRP).
Computer proficiency specifically with Microsoft Word, Excel, Project and PowerPoint.

Salary commensurate with experience and benefits available.

Interested candidates may send resumes via email to: [Click here for email].

EOE