About the Job

The Quality Systems and Compliance sub-team is under the remit of the Site Quality Department and is responsible for the quality system management (QMS) implementation within the site. The team is responsible for setting up or reviewing and auditing the quality management systems, third party and supplier management system, Training and Documentation systems to be used by the entire site, which is instrumental in ensuring the site systems and processes meet the international GxP requirements. The team is also responsible for the Data Integrity (DI) Program to ensure the compliance use of the digital initiatives. This includes working closely with the respective functional teams to provide oversight and guidance for data integrity and projects related to data integrity to achieve the site’s digital ambition while in compliance with data integrity requirements. Another aspect is to manage Quality Culture program, enabling the right Quality Culture to be embedded onsite. 

Documentation Management System:

• Support the implementation of digital documentation solutions like electronic logbooks and manage the GMP governance and issuance of paper-bound logbooks on site.

• Support the implementation of digital documentation solutions like electronic forms and manage the GMP governance and issuance of controlled printing of forms on site.

• Lead and implement framework and solution for document archival and destruction process on site.

Quality Culture Program/ Data Integrity:

• Support in the development and roll out the Quality Culture program onsite

• Tracking of Quality gaps and near misses, with the use of data visualization tool to communicate stakeholders

• Status tracking of identified actions in Data Integrity Plan

Site Inspection Readiness and Management

• Provide support for logistics activities for internal and external inspections. Provide support for site inspection readiness program.

Quality Projects

• Status tracking of Site Quality Projects.

• Provide support for identified site Quality Projects.

About You

• Degree or Diploma preferably in a related field

• Previous internship or work experience in any fields

• Candidates from Polytechnic or University programmes are welcome to apply

• Strong organizational and time management skills with the ability to manage multiple tasks simultaneously

• Excellent written and verbal communication skills

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