Senior Quality Assurance Specialist

Fraser Dove International; Basel; On-site; CHF 60,000 - 84,000; Full time

Job summary

Fraser Dove International supports a leading biopharmaceutical organisation by appointing a QA Senior QMS Specialist, Quality Systems & Training. The role centers on maintaining and improving QMS processes, especially LMS, document control, eQMS, and regulatory inspection readiness.

Ideal candidates have 7+ years in pharmaceutical QA/compliance, strong English communication and technical writing, and will support a global, multicultural workforce across international sites.

Qualifications

• 7+ years of experience in pharmaceutical QA or related field.
• Experience supporting regulatory inspections and audits.
• Strong technical writing and English communication skills.

Responsibilities

• Maintain and continuously improve key QMS processes, focusing on training, document control and eQMS.
• Develop and deliver GMP training across an international workforce.
• Improve English-language SOPs, training materials and quality documentation.
• Support regulatory inspections and customer audits.

Skills

QA experience

QMS

Document control

Regulatory audits

Training delivery

English writing

Education

Bachelor's degree in life sciences

Tools

LMS

eQMS

Audit software

Job description

Fraser Dove are supporting a leading biopharmaceutical organisation with the appointment of a QA Senior QMS Specialist, Quality Systems & Training.

This is a South Korea-based opportunity and will require relocation.

The role will take responsibility for maintaining and continuously improving key Quality Management System (QMS) processes, with a particular focus on:

Key focus areas

• Training and Learning Management Systems (LMS)
• Document Management and Document Control
• Electronic Quality Management Systems (eQMS) and Quality IT systems
• Regulatory inspection and customer audit readiness
• Developing and delivering GMP training across an international workforce
• Improving English-language Standard Operating Procedures (SOPs), training materials and quality documentation

We’re looking for someone with 7+ years of experience within pharmaceutical or biopharmaceutical Quality Assurance, Quality Systems or Compliance, alongside strong experience supporting regulatory inspections and audits.

Strong English communication, training and technical writing skills will be particularly important, as this person will play a key role in supporting a global and multicultural workforce.