Quality Technician

1) Ensure the required compliance to relevant internal standards, local and international quality, and

regulatory guidelines applicable to Good Manufacturing Practice for clinical trials supply chain

activities and drive vital improvements.

2) Maintain a good understanding of local and international regulations, and keeping abreast with

regulatory changes and developments.

3) Perform quality activities required by the Quality Management System. This includes scope such as :

a) Document control and training management

b) Perform pre and post review and approval of production batch records

c) Perform pre and post review and approval of label printing records

d) In-process check responsibilities for production and label printing jobs

e) Management of non-conformances (deviations, complaints and quality investigations) and

related corrective and preventive actions

f) Responsible for quality compliance of controlled temperature shipments

g) Approval of components and material specifications

h) Responsible for the release of client / Fisher supplied materials

4) Partner and collaborate to find opportunities and solutions related to regulatory and quality matters

impacting the business.

5) Responsible for quality reviews of process performance, product quality and of the Pharmaceutical

Quality System and supporting continual improvement.

6) Ensure that a timely and effective communication and escalation process exists to raise quality

issues to appropriate levels of management.

7) Perform ad-hoc duties as requested by line management.