Job Description

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.

Employment Type

  • Full Time

Details

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