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職位

General

· Performance of physical and chemical package material testing, excipients
testing, product stability, release and in-process control testing and
necessary trending analysis under Lean lab management.

· Performance of testing in accordance with cGMP regulations and
Roche/Genentech standards and China GMP requirement.

· Supporting manufacturing operations by timely completion of package
material testing and excipients testing.

· Continuous improvement of processes and technology, in collaboration with
ASAT, to drive right *** time and efficiencies

· Ensuring test methods are validated according to relevant cGMP and
pharmacopeias in collaboration with ASAT.

· Supporting investigations due to OOS, OOT, OOE and other production-related
issues.



Technical and Functional

Implement GMP compliance with global GMP standards and China GMP requirement

· Provide QC staff with technical guidance on test methods and relevant
procedures.

· Ensure timely generation and reporting of test results in support of
manufacturing operations.

· Ensure that data, documentation and laboratory processes are in a constant
state of regulatory compliance and inspection readiness.

· Ensure system, computer, change control and analytical data is reviewed,
evaluated and approved against established criteria.

· Ensure all laboratory operations including test execution, review and data
documentation follow cGMP procedures.

· Collaborate with Lab Support to ensure calibration and maintenance of
laboratory equipment and systems.

· Direct QC Staff in the timely resolution of issues, including
discrepancies, investigations and implementation of CAPAs.

· Escalate any potential quality issues revealed during QC testing or
processing of products, especially quality or regulatory issues with the
potential to affect product quality or regulatory compliance.

· Support regulatory inspections and partner audits.

· Provide QC technical support and oversight to CMO activities

· Approve protocols and reports (e.g. third-party QC labs, MSAT or QC
studies, etc.).

· Support testing requirement for counterfeit product and special requirement
Marketing