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Lead Quality Assurance Specialist

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This role offers an exciting opportunity to support stakeholders in the regular review and revision of Standard Operating Procedures (SOPs), maintain Quality Management Systems (QMS) for corporate and Taiwan GDP requirements.

What you'll do:

As a Lead Quality Assurance Specialist, you will play a pivotal role in supporting stakeholders' SOP review processes, making proactive recommendations for improvements, maintaining QMS for corporate requirements, providing regular updates on quality KPIs, acting as a regional and local quality document controller, participating in audits and inspections, assisting in investigating and correcting quality-related issues. You will also handle product complaints through internal systems, report adverse events to local authorities, coordinate product holds and product field actions. Your ability to collaborate effectively with various departments will be crucial in this role.

  • Support stakeholders in the regular review and revision of SOPs
  • Make proactive recommendations to RAQA and other departments to improve quality and efficiency
  • Maintain QMS for corporate requirements and Taiwan GDP requirements
  • Provide regular updates on quality KPIs to the regional QA
  • Act as regional and local quality document controller
  • Participate in all regulatory, corporate, internal, external audits and inspections
  • Assist in investigating and correcting quality-related issues through collaboration with other departments
  • Handle product complaints through internal systems, report adverse events to local authority, coordinate product holds and product field actions

What you bring:

The ideal candidate for the Lead Quality Assurance Specialist role brings proven experience from previous roles within regulated industries. You have a strong understanding of QMS maintenance for corporate requirements and are adept at regulatory compliance including SOP reviews/revision processes. Your ability to make proactive recommendations for improving quality and efficiency sets you apart. You have experience handling product complaints through internal systems and possess excellent interpersonal skills for effective collaboration with various departments.

  • Proven experience in Quality Assurance roles within regulated industries
  • Strong understanding of QMS maintenance for corporate requirements
  • Experience with regulatory compliance including SOP reviews/revision processes
  • Ability to make proactive recommendations for improving quality and efficiency
  • Experience handling product complaints through internal systems
  • Excellent interpersonal skills for effective collaboration with various departments

What sets this company apart:

Our client is a global leader in their field, known for their commitment to innovation, quality, and efficiency. They offer a dynamic and inclusive work environment that fosters creativity and collaboration. Their employees enjoy comprehensive benefits, continuous learning opportunities, and the chance to make a real impact in their roles. This is an exciting opportunity to join a company that values its employees and invests in their professional growth.

Contract Type: FULL_TIME

Specialism: Healthcare

Focus: RA & QA

Industry: Pharmaceuticals

Salary: Negotiable

Workplace Type: Hybrid

Experience Level: Associate

Location: Taipei

Job Reference: 3TLSRB-D6C57799

Date posted: 23 May 2024

Consultant: Rica Chuang

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