About the Role:

We are looking for highly driven individual with minimum academic qualification in Diploma in biology, biotechnology, life sciences or equivalent, to be part of our team as Quality Assurance (QA) Associate. Candidate is expected to have understand of laboratory and human cell culture skills and experience and are keen to pursue a career in the cell therapy manufacturing field. The candidate is expected to work closely with Production Team to support manufacturing needs.

Job Responsibilities:

• To assist with implementation of Quality Management System (QMS);
• To adhere to GMP and Quality Assurance System;
• To assist with internal/external audit and regulation inspection;
• To assist with yearly management review meeting and product quality review;
• To assist with documentation of all policies, processes, programmers, procedure and instruction and to communicate to all relevant personnel;
• To assist with set up of QMS and all documentations related to a GMP lab;
• To attend training, including but not limited to cell culture training for relevant production and all necessary GMP-related training in order to achieve the desired competency level;
• To assist with updating all regulatory requirement pertaining to GMP;
• To assist in ensuring equipment in the quality department are maintained, calibrated and validated;
• To participate in weekly and monthly cleaning and the maintenance of GMP facility;
• To assist in the preparation and review of standard operating procedures (SOPs) for various quality-related activities;
• To ensure incident reporting such as Deviation, Out Of Specification, Fault Notification, CAPA and etc are well recorded in the online sheet in a timely manner;
• To ensure all testing/monitoring such as QC form, microbial and particle testing report are available in Batch Manufacturing Record files;
• To ensure plates needed for environmental monitoring are available;
• To issue Batch Manufacturing Record (BMR) to production team on time;
• To make sure the laboratory cleanliness is maintained all the time;
• To perform routine checks on BMR;
• To ensure all testing reports are filled up together with BMR;
• To assist with product complaints/product recall investigation when necessary;
• To ensure all operators adhere to sterile processing to ensure the sterility of materials being produced;
• To assist in all other tasks assigned from time to time.

Location: Johor Bahru, Johor