101 Supply Chain Solutions Inc. QA Specialist

QA Specialist

101 Supply Chain Solutions Inc.

NT$7.8-10.5K[月薪]

现场办公 - 甲米地1-3 年經驗本科全職

Ensures compliance and assist in the implementation of Quality Management System (QMS), compliance to regulatory requirements, and GxP Standards (e.g. GDSP, GMP, GCP) as applicable
Initiate and implement quality initiatives and programs for continual improvement
Provides guidance to operational areas to ensure robust quality system
Effectively write, review, and/or approve documented procedures (e.g. SOPs, Work Instructions, Protocols, etc.) to ensure quality assurance attributes are met
Ensures proper documentation and archiving of QMS documents, along with maintaining traceability
Act as the Qualified Person in compliance to FDA regulations (e.g. license-to-operate)
Attends during regulatory inspections and customer audits
Develop, revise, maintain, and implement Quality Assurance policies, programs, and procedures
Conducts training of Quality Assurance related policies, programs, and procedures
Performs quality related tasks including but not limited to processing, reviewing, and documenting internal audits, change control, deviation/non-conformances, CAPA, Management Review, among others
Ensures that product and process deviations, non-conformities, complaints, recalls are reported, investigated, resolved, and documented properly
Develop, review, and conduct Risk Assessment and Quality Risk Management activities
Review/Approve validation projects, plans, protocols, and reports
Perform quality activities related to Supplier Management such as vendor assessment and audits, as necessary
Act as deputy in the absence of the Quality Assurance Manager
Assist with Quality Assurance Department functions as needed
Performs other tasks and duties which may be assigned

Bachelor’s degree in pharmacy, chemistry, chemical engineering, and other science-related courses
Must be licensed
In-depth knowledge of Quality Management System, Regulatory Requirements, and Good Industry Practices (e.g. Good Storage and Distribution Practices, Good Manufacturing Practices, Good Clinical Practices)
Computer literate with basic knowledge in MS Office
Exhibit attention to detail in all areas of work
Display excellent and effective communication skills, both verbal and written
Display effective and efficient data collection, management, problem analysis, and problem-solving skills
Planning and organizing tasks
Exhibit leadership and think strategically
Maintain a positive attitude and intrinsic motivation when solving problems
Be productive, organized, and able to manage deadlines
Has the ability to adjust to changing regulations, new products, new process, and/or technologies
Has the ability to prioritize projects appropriately, work with complex timelines, and meet department objectives
Has the ability to manage multiple projects while maintaining high quality outcomes
Ability to work proactively with workmates, both superiors and subordinates