System Validation and Data Integrity Specialist
Quality Chemical Laboratories is seeking a full time System Validation and Data Integrity Specialist. A Bachelor’s degree in an IT or related discipline with 2 to 4 years’ experience or an equivalent combination of education and experience is preferred.
Plans and writes protocols for computer system validation projects per 21 CFR Part 11 Reviews validated systems to assess need for further enhancements, validation, or system upgrades/fixes Works with company management to implement changes and upgrades to computer systems Works with vendors on purchasing and planning for changes and upgrades Ensures 21 CFR Part 11 compliance for all computer systems Initiates computer system change controls Ensures the validated state of all existing computer systems Reviews vendor protocols/design specifications for accuracy and feasibility for new computer systems Performs risk assessments for existing and new computer systems Monitors validation activities and communicates problem areas to quality assurance management Ensures the integrity of all data generated by validated computer systems Participates in client and regulatory audits providing support for inquiries regarding IT practices and procedures, system SOPs and computer system validations Collaborates with other representatives from the quality department to complete internal audits of the IT department and computer systems Coordinates end user training initiatives on new system rollouts Performs other related duties, as required Reports to the Quality Assurance Director.
A Bachelor’s degree in an IT or related discipline with 2 to 4 years’ experience or an equivalent combination of education and experience is preferred Experience in a pharmaceutical company preferred Excellent interpersonal and communication skills required Strong verbal and technical writing skills Must be results driven, a quick learner, and a self-starter