Title:  * Specialist Quality Assurance

Job Summary

• Recruit 2 positions: one for FMCG products (working location: VSIP 2) and one for Healthcare products (working location: VSIP 1).
• In charge for validation task: create validation plan, protocol, execution & report
• Ensure the quality management system in compliance with GxP standards, applicable SOPs, relevant laws and customer requirement

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
• Have basic knowledge about ISO, GxP
• 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
• Candidates with a pharmacy degree are preferred for the position responsible for Healthcare products
• #LI-TP1