Sr QA Specialist

Sr QA Specialist

Category: Quality Location:Taipei, Taiwan, TW

Key responsibilites

• Training Administration

• Operation at distribution partner

• Document control and administration

• Product Quality Complaint registration and processing

• Archiving and Record Management

• Support quality management system maintenance and effectiveness

Main job tasks * Support QMS/SOP management, including document control activities (e.g., preparation/review support, updates, and ensuring controlled documents are current).

• Training administration: Act as local training coordinator to distribute and coordinate assigned trainings to employees

• Support deviation management and CAPA execution: documentation support, ensure actions are implemented on time, tracking status to closure, supporting investigations under guidance

• Assist in vendor/distributor quality oversight, including follow-up of quality issues and documentation checks as assigned.

• Perform quality review of batch documentation and related release documentation within defined scope/authority (e.g., completeness/quality checks, coordination support).

• Handle product quality complaints, including data/document review support, case quality checks, and timely tracking.

• Participate in internal audits and Health Authority inspection readiness activities (e.g., meeting support, document readiness, CAPA follow-up) under guidance of senior QA colleagues.

• Collaborate with cross-functional teams and external partners to implement risk mitigation measures and ensure compliance with quality standards and regulations.

• Maintain accurate QA records and contribute to quality metrics (e.g., deviation/CAPA timeliness, overdue actions, recurring themes) for continuous improvement.

• Escalate quality risks promptly to the appropriate QA/Senior team members according to escalation procedures.

• Act as backup for affiliate Quality Responsible Person (QRP).

Key external stakeholders

Third-party distributor and repacker, local Health Authority, external archive service provider

Key internal stakeholders

Supply Chain, Commercial Operation \& Logistics, Regulatory Affairs, Commercial departments, Regional QA , Corporate Quality.

Innovation and change

• Implementation of advanced data analytics to identify trends and patterns in quality assurance data, leading to proactive identification of potential risks and opportunities for improvement.
• Utilisation of emerging technologies, such as artificial intelligence and machine learning, to automate and streamline quality assurance processes, reducing manual effort and increasing efficiency.
• Embracing a culture of innovation and change by actively seeking out and implementing best practices from the pharmaceutical industry, academia, and other relevant sectors.

Geographic responsibility

The position is based in the country where they are hired.

Education * Bachelor’s degree in a relevant field such as Pharmacy, Life Sciences, Chemistry, or Engineering.

Experience * Preferably 1–2 years of experience in the pharmaceutical industry (or equivalent regulated environment exposure).

• Basic understanding of GMDP, quality documentation, and compliance/quality mindset.

Qualifications

• Attention to Detail: Strong attention to detail and ability to work accurately with controlled documents.

• Communication: Good communication skills by able to articulate quality requirements and communicate quality requirements clearly with stakeholders.

• Collaboration: Ability to collaborate cross-functionally by supporting problem solving through coordinating actions, timelines, and follow-ups across teams. Showing accountability and responsiveness to Quality-related requests and priorities.

• Analytical Thinking: Ability to evaluate the quality of products and identify areas for improvement.

• Strong computer literacy (ability to work with standard office tools and learn systems quickly).

• Strong learning agility—quickly grasps new processes, tools, and regulatory/QMS requirements, and applies learning to day-to-day work.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.