Senior QA Engineer

Date Posted: Posted23 hari yang lalu

Salary:

Batam

Quality Control:

Work closely with MS&T to set out appropriate tests and acceptable result parameters. Ensure that quality testing throughout the manufacturing process is effective.
Proactive review and improvement of QC systems and processes to ensure the maintenance of standards. Improve the output quality of QC process by identifying and removing the causes of defects and minimizing variability in QC processes.
Employ risk analysis tools, problem-solving tools and statistical concepts to determine appropriate corrections required.
Analyze problems reported and develop improvements to overcome them related to QC processes and equipment. Identify and correct the causes of failures with the efforts to prevent them.
Develops sampling plans by applying attribute, variable, and sequential sampling methods. Establishes statistical confidence by identifying sample size and acceptable error.
Manage and maintain accurate quality engineering documentation, including SOP, risk assessment, master list of QC equipment, particle library, etc.
Responsible for the investigation of complex quality and compliance issues (e.g., CAPA, non-conformance, audit observations) for QC Operations.
Lead cross-functional or cross-site initiatives to drive change control and improvement projects. Responsible for multiple complex major projects requiring innovative solutions.

Validation:

Conduct re-evaluation, decommissioning and validation of QC equipment and software. Resolve deviations associated with re-evaluation and validation activities.
Manage the validation deliverables ensuring new QC equipment and systems are implemented within predetermined timelines, and develop remediation plans with minimal guidance and supervision.
Serve as a technical review of validation deliverables for QC.

QA Oversight/ Walkthrough:

Conduct QA oversight/ walkthrough at GMP area. Work closely with manufacturing staffs to ensure quality protocols are followed, documentation is correctly maintained, and implement any new changes or adaptations based on a quality review.
Drive and involve in process improvement in the manufacturing especially to improve GMP compliance.
Support other departments in investigation as required.

HSE:

Working in accordance with the HSE Manual and documented procedures, and reporting HSE issues to the respective area owners.
Ensure safety requirements are met at every point in the QC area, including HIRA, safety assessment before commissioning, etc.