Validation Lead Argos Therapeutics
THIS JOB HAS EXPIRED ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources.
Manage and implement validation and risk assessment activities for facilities, equipment and databases.
? Maintain and execute company Validation/Qualification/Risk Assessment Programs (e.g., utilities, equipment, material shippers, clean room, document management systems, process risk management).
? Ensure computer applications used to support regulated work are in compliance with FDA 21 CFR Part 11 and EudraLex 4.
? Manage and participate in the implementation of equipment installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ ) programs for site equipment/systems.
? Compile and analyze validation data, prepare reports and make recommendations for changes and/or improvements.
? As needed, manage and serve as the information resource for contractors and vendors hired to support validation activities.
? Assist user groups in troubleshooting and analyzing equipment for research, process development and cGMP processing and testing.
? Participate in project and task force meetings and provide assistance in the selection of equipment and software to help improve work practices or product quality.
? Assess new regulations and guidances on the use of equipment and computers in a cGMP environment and develop or revise programs to ensure compliance.
? Ensure that equipment is upgraded and/or operating as required during process transfers and validation.
? Manage department activities and ensure adequate resources to meet project requirements, timelines, and budgets.
? Develop, write, and execute procedures and protocols.
? Other duties as required.
? Bachelor-s degree in related field.
? Hands-on work experience with minimum 4+ years of equipment qualification, process validation, computer validation and clean room qualification experience in a pharmaceutical/biotech environment.
? Strong written and oral communication skills.
? Working knowledge of cGMPs, applicable standard practices and regulatory guidances.
? Knowledge of industry requirement/best practices for computer system validation, equipment qualification, risk assessments and process validation.
? Good interpersonal, organizational and trouble shooting skills.
? Ability and willingness to work effectively as a team member.
||4233 Technology Drive |
Durham, NC 27704
THIS JOB HAS EXPIRED