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GMP Auditor

1 week ago

Taguig, National Capital Region, Philippines DKSH Group Full time

Job Summary

We are seeking a qualified GMP Auditor to join our team at DKSH Group.

The successful candidate will be responsible for ensuring the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in accordance with regulatory requirements, industry standards, and company policies.

Key Responsibilities

  • QMS Development and Maintenance:
  1. Develop, implement, and maintain QMS procedures, policies, and documentation.
  2. Ensure alignment with regulatory requirements (e.g., GDP, GMP, FDA, EMA).
Quality Assurance and Compliance:
  1. Conduct internal audits and assessments to ensure compliance with QMS and regulatory requirements.
  2. Identify and address deviations, non-conformities, and corrective actions.
Training and Awareness:
  1. Develop and deliver training programs for employees on QMS policies, procedures, and regulatory requirements.
  2. Ensure awareness and understanding of QMS principles throughout the organization.
Continuous Improvement:
  1. Analyze data, identify areas for improvement, and propose corrective actions.
Change Control:
  1. Collaborate with departments to implement changes and enhancements.
Documentation and Record-Keeping:
  1. Maintain accurate, complete, and controlled QMS documentation.
  2. Ensure compliance with document control procedures.
Vendor Management:
  1. Collaborate with suppliers, contractors, and third-party logistics providers to ensure QMS compliance.
Customer Complaints and Feedback:
  1. Investigate and address customer complaints related to quality.

Requirements

  • Demonstrate good knowledge of ISO 9001:2015 requirements.
  • Demonstrate proficiencies in office productivity tools (e.g., MS SharePoint, MS Word, and Adobe Acrobat).
  • Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions.
  • Demonstrate fluency in local language and ideally in English, both written and spoken.

Benefits

  • Opportunity to work with a leading global business services provider.
  • Chance to develop your skills and expertise in quality assurance and regulatory compliance.
  • Collaborative and dynamic work environment.