Production Quality Specialist

Description

Assist Production Department Manager to prepare a yearly quality assurance plan to all employees and ensure its execution.

Supervise that the responsible function is in compliance with all relevant guidelines, cGMP and regulations through self-inspection/spot check and document reviewing.

• Coordinating the deviation/change control/complain initiation/investigation/effectiveness check, critical deviation / change control following up, etc.
• Ensure that all operations in the Operation Department are following cGMP. Coordinating compliance team to investigate complaint. Involve compliance team in GMP/productivity project. Be able to analyse operations related data and use risk assessment tools
• Enrol in internal quality system audit and take the responsibility of follow up actions. Initial deviation/change control/complain investigation and follow up all the Operation Department observations from internal/external, deviations and change controls close out.
• Responsible for the introduction of relevant instruments in the production department, data review, and data integrity etc.

Qualifications

• At least 3 years of working experience in the pharmaceutical or related industry with minimum 2 years of quality/operation management experience.
• A bachelor's degree or above in a major related to pharmaceutical, food science, or chemistry.