Validation Engineer 確效工程師

Job content

Duties & Responsibilities

· Define and review validation, qualification and GMP complains related regulations, code and standards (TFDA and international GMP shall be considered)

· Develop and update project validation master plan.

· Review and update project GMP risk assessment.

· Lead the qualification team to develop qualification plan for process, clean room / HVAC, critical utilities, EMS, any associated system.

· Coordinate with design team for DQ review and design GMP upgrade.

· Drive the qualification team to develop, review and update GMP risk assessment, system impact assessment for the project.

· Drive the project qualification team to develop / review URS, DQ, IQ, OP, PQ protocol for process, clean room / HVAC and critical utilities system.

· Lead the project qualification team, vendor and client operation team to execute DQ, IQ, OQ and PQ for clean room / HVAC, EMS critical utilities system.

· Lead project qualification team, vendor and client process team to execute DQ, IQ, OQ and support PQ execution for process system.

· Filing & organization of all the associated documentation by following the project specific document control procedure / requirement.

· Provide qualification summary and validation summary report.

· When applicable, conduct or join the needed meeting in order to facilitate validation and associated interfaces.

· Coordinate with internal and external stakeholders in terms of validation and associated interfaces. Stakeholders include but not limited to the Client, internal project team, vendors / subcontractors, consultant, authority etc.

· Other tasks assigned by department manager.

Education:

major: Chemical Engineering / Chemistry / Bio-medical Engineering

Types of Experience:

Full-cycle experience of validation planning and execution.

Prefer to have quality control / quality assurance experience.

Practical Skills:

GMP, GAMP

Validation

Risk Assessment

Quality Assurance

Process (Life Science)

Regulatory Affairs

Language: Chinese and English