Title: Specialist Quality Assurance
Binh Duong, VN, VN
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