Engineer, Quality Validation

. JOB PURPOSE: To provide leadership and guidance on validation/qualification initiatives to internal project teams and external validation firms in order to ensure schedules are met and that systems, both computer and equipment are in compliance with regulatory requirements.

KEY ACCOUNTABILITIES:

Description Policies, Processes & Procedures.

 Follows all relevant departmental policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner.

Day- to-day operations

 Follows the day-to-day operations related to own job to ensure continuity of work.

Job Specific Accountabilities

 Ensures that all deviations related to the validation process are fully investigated in order to identify validation issues and close investigations.

 Implements follow-ups on the proper implementation of corrective and preventative measures to address quality validation deviations.

 Provides direction on Equipment/Computer Change Control development in order to facilitate the assessment of lifecycle documentation which includes computerized systems records and capabilities.

 Collaborates with higher level engineers on the development of training materials in order to train colleagues on polices and procedures that include requirements for quality validation.

 Provides technical support to Manufacturing and other departments to resolve validation-related exceptions and deviations.

 Performs a periodic review of systems to monitor the validation status of as well as the annual security audit in order to ensure that the system’s validation state is maintained through proper 2 Confidential testing as part of the change control program and re-validate as necessary.

Continuous Improvement

 Contributes to the identification of opportunities for continuous improvement of processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement Reporting.

 Assists in the preparation of timely and accurate reports of quality to meet company and department requirements, policies and standards Safety, Quality & Environment

 Complies with all relevant safety, quality and environmental management policies, procedures, and controls to ensure a healthy and safe work environment. Related Assignments

 Performs other related duties or assignments as directed.