Job Description
We are seeking a skilled Validation Engineer to join our team. In this role, you will be responsible for creating and executing validation documentation and coordinating validation activities for moulding, assembly, testing equipment, computerized systems and facilities within the quality management system.
Main Responsibilities:
* Write the necessary validation plans, protocols, reports and amendments of the Quality Management System ensuring compliance with the latest Regulatory Agency directives / requirements within the Medical Device and Pharma Sector.
* Generate applicable quality documentation in conjunction with validation activities.
* Liaise within a cross-functional team to provide and drive validation inputs and initiatives into the overall operational activities of the company.
* Liaise with external vendors for validation plans and requirements.
* Development of validation projects, master validation plans.
* Support the implementation of Company Policies and GMP.
* Support all company safety and quality programs and initiatives.
* Ensure ongoing compliance with GMP in all practices, recording of events and processes.
* Ensure compliance with all learnings from all GMP training events.
* Perform and generate risk assessment documents for regulated processes within the scope of the QMS.
* Participate in and drive quality GMP audits.
* Knowledge and use of LEAN 6 sigma tools for problem solutions.
Requirements
To be successful in this role, you will need:
* A degree in Engineering/Science discipline.
* At least 3 to 5 years' experience in a Validation or Quality Engineering role.
* Strong working knowledge of process validation and capability.
* Strong working knowledge of validation and quality principles and practices with key emphasis on EudraLex, ISO13485, ISO14644, GAMP5 and FDA Pharma and medical devices regulations.
* The ability to work in a cross-functional team environment, with excellent initiative, decision-making and drive for achieving results.
* Excellent technical report writing, time management, computer and presentation skills.
* Excellent interpersonal and communication skills.