About the role
Significant growth within this high performing logistics (pharmaceutical and med device) business has seen the need for a full time Validation Engineer to join the technical team, initially in a 3 month contract position with a strong possibility of the role becoming permanent. In this role, you will be responsible for ensuring that all GxP logistics processes and equipment, and computer systems are operating within established guidelines, standards, and regulatory requirements.
As the Validation Specialist, you will be responsible for implementing the validation and calibration program and meeting the requirements of high-needs customers. You will work closely with cross-functional teams to identify potential risks to product integrity associated with logistics processes and conduct root cause analysis to develop action plans to address validation issues.
Responsibilities:
- Implement the Validation and calibration programme for facilities, processes, and equipment
- Conduct period reviews and report on the validated state to determine the ongoing requalification requirements for pharmaceutical logistics processes, equipment, and computer systems
- Identify and evaluate potential risks to product integrity associated with logistics processes
- Perform root cause analysis and develop action plans to address issues related to validation of GxP logistics processes
- Stay up-to-date with new regulatory requirements and industry best practices related to qualification for GxP logistics
- Collaborate with cross-functional teams to develop and implement corrective and preventive actions
Experience and Qualifications:
- Bachelor's degree in Science, Engineering or related field
- Experience in validation or qualification within the pharmaceutical or medical device industry
- Knowledge of local and overseas regulatory requirements and industry standards related to qualification of pharmaceutical logistics processes, such as Medsafe, FDA, TGA, and EU regulations
- Excellent written and verbal communication skills
Benefits:
- 3 month contract with excellent potential to become permanent
- Work alongside and experienced and collaborative team
- South Auckland location
If you are a self-starter, possess excellent problem-solving skills, and have a passion for ensuring compliance with regulatory requirements, make sure to contact your job search specialist!
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