About the role

Aplyr's Quick Take

This role is focused on managing the Quality Management System (QMS) to ensure compliance with ISO standards in a healthcare setting. You'll be creating and maintaining procedures, preparing for audits, and collaborating with various internal teams and global counterparts. It's primarily an individual contributor role with a strong emphasis on quality assurance in the pharmaceutical or medical device industry.

Good fit

Ideal candidates have 3-5 years of QA experience in healthcare, particularly in pharmaceuticals or medical devices. Strong document management skills and fluency in English and Korean are essential, along with the ability to work independently and communicate effectively with diverse teams.

Worth noting

The role requires interaction with global teams, which may involve occasional travel or remote collaboration. The focus on ISO compliance and preparation for audits indicates a high-stakes environment that may not suit everyone.

Responsible for the site QMS procedure and strategy to be compliant to ISO 9001, ISO 13485.
(Some of process to be compliant to pharma industry GMP)

Main Responsibilities & Tasks:

Create and maintain local QMS SOP compliant with ISO 13485 and applicable Sartorius Global procedures (Change control, QI/NC, CAPA, Internal Audit, Supplier management, Management Review etc.)
Analyze gap between different levels of global procedures to prepare best-harmonized local procedures
Get ready for ISO 9001 certification audit and external customer audit as a supplier to the bio-process pharma customer.

Interfaces:

Local: As a site quality almost, all functions are internal customer and counter-part
Global: Occasionally this person needs to contact equivalent scope of other Sartorius site people mainly located in France, German, US and China.

Qualification & Skills:

Bachelor’s degree in science or quality related (Bio, Medical etc.)
3~5 years’ well-proven work experience in healthcare (Pharmaceutical/medical device industry) as a QA
Strong in document/record management skills.
Experienced with regulatory body inspection/customer audit in healthcare industry.
Fluent English communication capability
Professional people management experience and skill
Good command of both English and Korean

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers

Aplyr's read

Sartorius is a leader in bioprocess solutions, attracting professionals in biotechnology and laboratory equipment, committed to advancing pharmaceutical innovations.
Synthesized from recent postings & public sources

What's promising

•Sartorius is a key player in the growing bioprocess solutions market.
•The company offers diverse roles from technical sales to scientific research.
•Sartorius invests in innovation, driving advancements in laboratory and pharmaceutical equipment.

What to watch

•The specialized nature of roles may limit opportunities for non-experts.
•Global operations could lead to complex organizational challenges.
•High competition in the biotech sector may pressure profit margins.

Why Sartorius

•Sartorius specializes in both bioprocess solutions and laboratory products.
•The company has a strong presence in the pharmaceutical equipment sector.
•Sartorius offers roles in cutting-edge fields like gene therapy and chromatography.

Aplyr’s read is generated by AI from public sources. Was it useful?