『保瑞-桃園廠』品保副理 QA Associate Manager

Responsibilities:
•Review technical problems, and subsequently suggest and debate alternative methods and procedures to solving problems or changes in procedures.
•Modify product assurance programs to clarify areas or roles of responsibility, staffing requirements, and operational procedures.
•Supervise and final approve investigations relating to root cause of customer complaints, manufacturing, and laboratory deviations, and review, approve and implantation oversee corrective and preventative actions, and effectiveness check as required.
•Support Supplier Quality Management program for supplier qualification and supplier risk management.
•Ensure quality assurance of newly designed and manufactured products by supporting manufacturing and QA’s investigations and to confer with engineers to rectify problems.
•Ensure the practicable goal for quality metrics are established and the performance are monitored for continually improvement.
•Develop and maintain a suitable documentation control system to ensure compliance with applicable regulations and procedures.
•Develop and maintain a suitable training system to ensure compliance with applicable regulations and procedures.
•Develop, review and approve GMP documents (e. g., standard operating procedures, forms, validations, batch records and specifications, etc.) to ensure compliance with applicable regulations and customer’s quality requirement.
•Ensures release of raw/packaging materials and finished products met criteria and compliance.
•Oversee the management of the analytical database for inter-department use, and ensure valid evaluation of stability trend and analytical data.
•Manage EM, CV, Cross Contamination program, data collecting and generating reports
•Oversee the equipment qualification and computer system validation procedure to meet company and regulatory requirements.
•Monitors the QA systems for improvement, review/approval function for GMP documents.
•Provide hands-on training and reinforces cGMPs concept to increase quality and compliance knowledge throughout manufacturing site.
•Ensure all activities and operations met cGMP compliance. Monitor regulatory updates and industry news to ensure site compliance.
•Review and oversee quality risk management of the site for risks evaluation, control and mitigation as required.
•Other tasks as assigned by the company.

Qualifications:
•This position requires an MS degree or above in chemistry, biomedical, or engineering related background and with 4 years of pharmaceutical industrial experience or above (preferable for aseptic operation). Or equivalent combination of education and experience.
•Requires the ability to provide guidance to junior staff under supervision and is a steppingstone to more senior QA leadership positions. It requires strong technical knowledge, communication skills, and attention to detail.

cGMP Compliance:
Demonstrated experience in current Good Manufacturing Practices and regulatory standards.
•Computer Skills:
Proficient in Microsoft Word, Excel, and PowerPoint.
•Language Proficiency:
Fluent in both spoken and written English and Mandarin.
•Core Competencies:
Leadership: Takes ownership of team performance; provides feedback, supports development, and manages employee relations.
Delegation: Assigns tasks clearly; empowers team members while ensuring accountability and results.
Quality Focus: Committed to continuous improvement, accuracy, and thoroughness in QA processes.
Problem Solving: Identifies issues, evaluates alternatives, and implements effective solutions within teams.
Oral Communication: Articulates ideas clearly in meetings and presentations; listens and responds effectively.
Written Communication: Produces well-structured, clear documentation; presents data in a concise and informative manner.