· Ensure all aspects of activity within the Quality Engineering Group adhere to required policies and procedures, including safety and training.
· Ensure that the plant meets the quality requirements of its customers with respect to Validation and Calibration, ISO 9001:2015 / ISO 13485:2016, In Vitro Diagnostics Directive, Division & Corporate Policies and other external standards.
- Be involved in all Validation Cross Functional Teams (CFT’s) at the site to ensure adherence to required policies and procedures, including safety and training.
- Assist in preparation and execution of validation protocols.
- Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
· Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues.
- Lead validation aspects of Facility, Utility, Equipment qualifications
- Conduct Test Method Validation, Gauge R&R
- Lead software validation and 21CFR Part 11 assessments
· Assist in the development of the existing Validation Program at AIDD to ensure continued compliance to the necessary regulations.
· Collate and Report on relevant Validation data/matrices.
· Ensure prompt attention to the Quality Engineering Manager on areas of non-compliance.
- Ensure all Validation and Calibration documentation meets the requirements of Quality Records Procedures.
· Develop and rollout ‘Validation Training’ for the site on subjects assigned by the Quality Engineering Manager.
· Keep abreast of developments in customer requirements to ensure the plant continues to produce quality products under regulatory requirements.
· Liaise with and seek appropriate advice from other company plants worldwide.
· Participate as required in project activities to achieve plant goals.
· Ensure all relevant employees are aware of Division and relevant International Standards and their implementation throughout the plant.
- Participate in identifying and implementing cost reductions, which do not adversely impact product quality.
- Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager.