Specialist Quality Assurance

Job Summary

• In charge for validation task: create validation plan, protocol, execution & report
• Control and ensure the quality product meet to requirement of quality system, current SOP, regulation & quality agreement from client.

General Responsibilities

• Prepare periodic qualification/ validation plan, prepare protocol, ensure the validation activities to be implemented under the current plan or changing activity related to quality
• Raise change control report that o related validation activity
• Detect & report to Manager any deviation
• Implement the assigned CAPA on time
• Participate in the authority inspection, external audit organization (e.g. ISO), client audits and in internal audits annually
• Participating in preparing / updating / management SOPs, WIs in QA department as assigned
• Implement all SOP/WIs that related to quality, quality agreement with clients
• Other tasks or duties assigned by superior.

Functional Skills and Knowledge

• Minimum of 01 -year working in QA role
• Experience with multiple aspects of the process development, analytical characterization, process scale-up
• Careful, hard-working, honesty and dynamic, high sense of responsibility, teamwork spirit
• Able to function within a quickly changing working environment with a high stress level and continuous time pressure
• Computer office skills
• Good in communicate skill.
• Good at verbal English
• Read and understand the SOP

Education

• Intermediate degree