Title: Laboratory Systems Validation Consultant
Responsible for performing duties related to computer systems validation project management. Includes attending status meetings, strategy meetings and other required meetings as well as maintaining the validation timeline and status for validation projects.
• Manages the activities of validation consultants utilized to assist in the implementations.
• Develops and reviews validation documents and implementation documentation that supports required validation activities. Documents include Validation Project Plan, Requirements and specifications, vendor Evaluation Documentation, Installation/Operational/Performance Protocols and Final Reports.
• Provides technical assistance, training and work direction to other staff members.
• Write protocols that challenge the critical parameters related to installation, operation, and performance of the related chemistry and microbiology laboratory computer systems or equipment, and assures that protocols are approved through proper channels.
• Researched and recommends changes; writes and revises validation protocols and procedures.
• Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
• Interacts with all affected personnel in the execution of protocols and gathering of test data. Ensures that all test data is gathered and recorded in accordance with cGxP requirements and industry trends.
• Analyzes data to ascertain that it meets related protocol acceptance criteria. Writes deviation reports as required upon failures to meet protocol acceptance criteria.
• Writes final reports and ensures that they are approved through proper channels.
• Develops and communicates project timeline and status.
• Carries out responsibilities in accordance with the organization’s policies and procedures, state, federal and local laws. Performs related duties as assigned.
• Current Good Laboratory Practices (cGLP), Food and Drug Administration (FDA), and related federal, state and local laws, codes, regulations and regulatory requirements.
Experience with validating global IT systems.
• Pharmaceutical quality control processes.
• Principles and practices of qualification and validation in accordance with USP ?1058? and GAMP5.
• Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations.
• Pharmaceutical principles, practices and applications.
• Personal computer operations and Microsoft applications (Word, Access, and Excel).
Must have a Bachelor’s degree in related field from an accredited college or university, and nine (9) to thirteen (13) years progressively responsible related experience preferably within the pharmaceutical industry. Knowledge of management systems and enterprise-type systems. Familiarity with USP ?1058?” experience validating laboratory equipment in a pharma environment.