Overview
Senior Quality Assurance Manager Jobs in Taiwan, Taiwan at Citadel Search
Title: Senior Quality Assurance Manager
Company: Citadel Search
Location: Taiwan, Taiwan
Our client in the pharmaceutical industry specialises in Oral Solid Dosage (OSD) production. They are seeking a highly experienced Director/Senior QA Manager to oversee the development and implementation of their product assurance program, complying with regulatory standards including FDA, EMA etc.
Job Responsibilities:
Develop, implement, and maintain comprehensive quality programs that adheres to company and regulatory standards of pharmaceutical production from in-coming raw materials to out-going finished goods(OSD products) in a CDMO environment.
Enhance the product assurance program with global best-in-class practices.
Ensure cGMP compliance and systems and procedures deployed are in compliance with regulatory requirements.
Drive internal and external audits to ensure compliance with regulations such as US FDA and EU
Maintain strict adherence to cGMP regulations.
Develop the Supplier Quality Program to ensure production of OSD products meet quality standards, and that their capabilities, competence and capacity meet rising production demands.
Oversee the release of raw materials and finished products, ensuring they meet required quality standards.
Lead the QA teams to solve quality issues in collaboration with production team.
Manage the analytical database for cross-departmental usage, ensuring proper evaluation of stability trends and analytical data.
Monitor and maintain Quality Management System, ensuring data integrity & internal controls are implemented and effectively translated into Quality SOPs in the pharmaceutical manufacturing plant.
Job Requirements:
A Bachelor of Science / Pharmaceutical Science or an M.S. degree.
A minimum of 10 years of experience in the pharmaceutical industry, with at least 4 years of relevant experience in leadership.
Strong QA operations experience in a cGMP environment is essential.
Proven leadership abilities, including experience in managing teams, conducting performance reviews, and fostering employee development.
Strong delegation skills and to drive an empowering work culture in the QA team.
In-depth knowledge of quality management practices, with a focus on driving continuous improvement.
Excellent problem-solving skills, with the ability to quickly identify issues and develop effective solutions.
