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The Position

Job Summary:

Product Release

Perform Product Release tasks following defined business process, ensure all relevant interfaces with manufacturing, QC within RDSZ and interface with corresponding QA organization outside of RDSZ is well integrated from both process and SAP perspective.Provide product release related KPI trending in timely manner.Representative from RDSZ QA in product release and document management area in global network, including develop/setup interface corresponding interface process with other QMS.

Product Partnering and Improvements & Resolutions Management (IRM)

Be Product Partner and collaborate with business partner to achieve process excellence.Be responsible for IRM implementation within RDSZ and ensure variance, OOS, NC and CAPA is carried out in accordance with IRM Global Standard Process within RDSZ.Monitor IRM cases through Daily Management or other tools, follow up IRM cases in a timely manner.Ensure the reprocess/rework process is followed in RDSZ.Routine shop floor management and participate in manufacturing process improvement projects.Review related procedures (SOP, specifications etc.) to ensure the regulatory requirements are met.

Change management

Establishment and safeguarding of the local change board at RDSZ as to ensure compliance with internal (Roche Policies, Divisional Quality Standards) and external regulatory requirements (ISO 13485, IVDD/IVDR, GMP, NMPA and AISA countries’ specific regulatory if applicable) within Operations and other QM-relevant processes.Participate in change control management as QA role, including local changes and dual-site changes. Drive change project lead and subject matter experts in RDSZ and dual site (such as CPS) implement local change and dual site change in a compliance manner.Monitor change control cases through Daily Management or other tools; follow up changes in a timely manner and provide KPI data.Owner of change control process (both local dual site changes) in RDSZ.

Handling of logistics claim for RDSZ outbound products

Setup RDSZ local logistics claim handling process for outbound products. Coordinate logistics claims investigation to ensure case investigation is completed in time and feedback conclusion to logistics claim system.

Audit support

Support internal and external audit and timely provision of records requested by inspectors.

Other tasks assigned by line manager

Qualification & Experience:

A Bachelor’s degree in Life Science, pharmaceutical engineering or related subject.Competent with routine application of MS OfficeAt least five years in the Medical Device/Pharma/Biopharmaceutical industryHas worked in more than one function within quality management and may have worked outside of Quality Management.  Can managing highly complex and/or global projects, or equivalent experienceKnowledge of the European, US, China and International cGMP regulations

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.