As a quality assurance associate, you will be responsible for ensuring products and business processes meet GMP, EU GMP, and local requirements.
Your main responsibilities include:
● Reception, reconciliation, and QA review and release of incoming material.
● Handle and QA review of deviations.
● Cooperate with process owners and heads of the quality unit in any issue impacting product quality, patient safety, and QMS compliance.
● Review of BPR, BMR, and BCR.
● Responsible for receiving CAPA and forming the meeting then following the agenda to meet the desired results.
● Responsible for receiving and QA reviewing change requests.
● Active role in the identification of risks of processes and implementing beneficial approaches to reduce the risk.
Requirements
● Bachelor's or Master's degree in Chemistry, or other related fields.
● At least 3 years of quality assurance experience in the pharmaceutical industry.
● Demonstrate knowledge of quality assurance and GMP, ICH, and PIC/S compliance.
● Experience in reviewing batch records, quality control data, and regulatory inspections.
● Ability to manage multiple priorities with a deadline.
● Able to work independently and be a good team player.
● Highly organized and detail-oriented.
● Fluent in English.
● Ability in working with computers and having an ICDL certificate is an advantage.