Qc Engineer

Quality control test engineer/specialist responsible for detail design lab facility, instrument. Primary contact of quality control test related with material, product , and process suitability confirmation. Expert on microbiology, chemical and physical test of subjected material.

Responsibilities:

• Review list of material, product, test method, instrument list to design intended scope of the work.
• Review and decide right spec of instrument to be procured. Develop test method if needed.
• Communicate with contract lab, external lab for tech transfer.
• Participate QC instrument, process equipment, and other facility & utility qualification process by providing service related with test plan, test execution and report with documentation.
• Design and standardize sampling scheme, test scheme and procedures as SOP/WI.
• Contribute process improvement.
• Set strategy for clean room qualification & monitoring plan for non-viable and viable particles based on risk analysis of product, production environment, and process aligned with sending site knowledge.
• Plan for lab project to be aligned with construction schedule and clean utility IOPQ.
• Prepare local procedure for clean environment monitoring & control.
• Prepare local procedure for product monitoring & control for viable and non-viable particles.

Interfaces:

• Production site Quality, Local Process Engineering, Local Construction project engineering, Procurement

Qualifications & Requirements:

• Minimum of a Bachelor’s degree in Microbiology, or related to life science
• Min. 10 years’ well-proven work experiences in microbiology QC/QA.
• Experienced aseptic production related quality control
• Strong risk assessment knowledge
• Strong problem-solving methodologies knowledge
• Skill to drive objectives or persuade stakeholders based on scientific/regulatory rational.
• Project management experience: implement, master and track timing plan, key performance indicators and action plan.
• English communication capability

• Experienced with group of people management skill