Job Title: Assurance Specialist
This role involves creating and executing validation documentation, coordinating validation activities within the quality management system.
* Write validation plans, protocols, reports, and amendments to ensure compliance with regulatory agencies.
* Develop quality documentation in conjunction with validation activities.
* Collaborate with cross-functional teams to drive validation inputs and initiatives.
* Liaise with external vendors for validation plans and requirements.
* Manage validation projects and master validation plans.
* Ensure ongoing compliance with industry standards in all practices and recording of events and processes.
Key qualifications include a degree in Engineering or Science, 3-5 years' experience in validation or quality engineering, strong knowledge of process validation and capability, and excellent technical report writing and communication skills.
Requirements
Validated documentations and reporting will be critical in this role. The successful candidate must have strong analytical and problem-solving skills, as well as excellent written and verbal communication skills.
* Excellent attention to detail and ability to work accurately under pressure.
* Strong organizational and time management skills.
* Ability to work effectively in a team environment.