Quality Assurance Engineer
TalentSource is an Executive Search company providing value-added talent solution to MNC and local clients. We build meaningful and rewarding relationships between top-tier executives and our valued clients, while actively catering to both parties� need for confidentiality, dignity, integrity and professionalism.
Responsibilities
Provide Quality and GMP governance and oversight to safeguard the quality and safety of products.
A subject matter expert who provides guidance for quality solutions on operational problems, issues at all levels of the business, ensuring compliance to regulatory standards.
Analyse and report quality data, determine and process change requests and concessions.
Facilitate the closure of field complaints and out of box failures, be able to determine and implement on-going improvements.
Requirements
Bachelor degree with at least 5 years quality experience in pharmaceutical, medical device or highly regulated industries.
Experience in volume manufacturing, good knowledge of FDA Quality System Regulations, GMP and appropriate ISO Standards, with the understanding of total quality and best practices.
You will be a self-starter, with the ability to work with minimal supervision and a sense of urgency.
Strong planning, organisational skills and self-motivated attitude.
