Job Title: Quality Assurance Specialist
About the Role:
We are seeking a skilled Quality Assurance Specialist to ensure the quality of our products through validation documentation and coordination of validation activities.
Key Responsibilities:
* Create and execute validation plans, protocols, reports, and amendments to meet regulatory directives within the Medical Device and Pharma Sector.
* Develop quality documentation in conjunction with validation activities.
* Liaise with cross-functional teams to drive validation initiatives into operational activities.
* Liaise with external vendors for validation plans and requirements.
* Develop and implement validation projects and master validation plans.
* Implement Company Policies and GMP guidelines.
* Support all company safety and quality programs and initiatives.
* Evaluate ongoing compliance with GMP in practices, recording of events, and processes.
* Ensure compliance with learnings from GMP training events.
* Generate risk assessment documents for regulated processes within the QMS.
* Participate in and drive quality GMP audits.
Requirements:
* 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.
* Experience in method validation and process characterization is an advantage.
* Strong working knowledge of validation and quality principles and practices.
* Ability to work in a cross-functional team environment.
* Excellent technical report writing, time management, computer, and presentation skills.
* Excellent interpersonal and communication skills.