JOB PURPOSE
- Responsible for the proper and timely implementation of Quality Assurance Policies & Procedures
- Responsible for advising on needed changes and improvements by providing training, tools & techniques allowing others to achieve set quality standards
DUTIES AND RESPONSIBILITIES
1- Write and update SOPs and work instructions for all departments to be submitted to Senior QA for revision
2- Perform all needed tests and studies (Bracketing-Worst Case study, mapping protocol, packaging validation, room and equipment validation) and make sure all processes and systems are as per set guidelines
3- Assess the impact of each machine component take corrective/preventive actions to ensure the best quality of products
4- Conduct training sessions to all plant staff on any new or updated SOP, basic GMP requirements, and other trainings according to the training schedule set by the Senior QA Specialist
5- Conduct calibration of device and equipment and ensure all are within their shelf-life, in order to get accurate results; prepare related certificates of calibration
6- Handle Pest Control tour with the external company to avoid any pest infestation
7- Assist departments in the issuance of all forms (DIR, OOS, CCF, RA, CC, and CAPA)
8- Gather data for annual review related to production, percentage of waste and analytical data
9- Conduct Gemba Walk; prepare HIRA forms and submit to Senior QA Specialist for review
Education
Bachelor's of Engineering in Chemical Engineering
Experience
Up to 1 year of previous related experience