Job Title: Quality Assurance Specialist
About the Role:
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team. As a key member of our quality management system, you will be responsible for ensuring compliance with regulatory requirements and industry standards.
Main Responsibilities:
* Develop and implement validation plans, protocols, and reports to ensure compliance with GMP regulations;
* Coordinate cross-functional teams to drive quality initiatives and operational activities;
* Liaise with external vendors to obtain validation plans and requirements;
* Support the development of validation projects and master validation plans;
* Ensure ongoing compliance with GMP in all practices and processes;
* Perform risk assessments and generate risk assessment documents for regulated processes;
* Participate in quality audits and drive improvement initiatives using LEAN 6 sigma tools.
Requirements:
* Degree in Engineering or Science discipline;
* 3-5 years of 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;
* Excellent technical report writing, time management, computer, and presentation skills;
* Excellent interpersonal and communication skills.
Benefits:
* Pension Fund;
* Medical Aid/Health Care.