在羅氏，我們鼓勵每位同事展現真實的自己；我們欣賞獨特且出眾的品質。羅氏的文化鼓勵積極的表達、開放的對話和真誠的連結，在這里，你將因為做自己而被重視、接納和尊重，并得到個人的提升和職業的發展。所有的這一切，都是為了更好地預防、阻止和治愈疾病，并確保醫療資源的可及性和可持續性。歡迎加入羅氏，一個重視每種聲音的地方。
職位
Principle Roles & Responsibilities / Accountabilities (Majfunctions of the
position)
1 Quality Oversight
Collaborate with key stakeholders including manufacturing operations, supplier
quality, quality systems Planning; provide Quality oversight in Drug
Products life cycle the E2E manufacturing process.
As per the business arrangement, the scope of quality oversight should cover
the quality activities in all related areas including QC laboratory, production
plants, site PUW, PW, Environmental Monitoring (EM) Clean Utility
Monitoring programs, etc.
·?????? Manage oversee frontline QA activities in plants.
·?????? Manage of sampling process flocal manufactured products
·?????? Perform oversight of Specification, process product monitoring f
local manufactured products
·?????? Perform oversight of stability program flocal manufactured products
·?????? Connection with Global Quality, take role as quality role across the
local manufactured product life-cycle management (Local Quality Role)
·?????? Execution of frontline QA activities in plants
? Acknowledge the live status in production area according to the DPS
follow up with actual excursions against the DPS, identify the potential risks
take preventive action.
? Join Tier meeting in production other Tier meetings
? Perform batch record review
? Enabling real-time problem solving with production team
2 Implement local manufactured product-related batch release process
·?????? Ensure on-time batch disposition per the requirement of Roche Timeline.
·?????? Ensure products are not sold supplied before a QP/AP has released,
each production batch is produced controlled in accordance with the
requirements of the Marketing Authorization other regulations relevant
·?????? Perform the interaction with EU QP regarding exported batches.
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3 Execution of API/direct materials management
·?????? Ensure on-time material batch disposition per Roche requirement
·?????? Implement oversight of material quality including Specifications,
Artwork, SAP/MES master data, Change, Deviation/CAPA, new material
qualification, quality management etc.
·?????? Support local supplier quality management including audit, Quality
Agreement etc.
4 Coordination handling fquality related issue
·?????? Implement the management of Event&CAPA：Be familiar with RCA tools
can independently facilitate related departments to conduct discrepancy
investigation, ensure the investigation completed within specified due date
supporting products release.
? Collaborate with SMEs Lead investigators to develop investigation
strategies
? Provide leadership fLocal Quality Review Board participate in Quality
Council when needed.
? Monitinvestigation progress ensure effective corrective
preventive actions are initiated executed on time keep continuous
improvement
·?????? Handle customer complaint
? Perform customer complaint investigation ensure effective corrective
preventive actions are initiated executed on time
? Lead the investigation of local manufacturing products related complaints.
5 Quality system oversight
·?????? Execute QA process/documentation maintenance in a continuously
compliant state a continual state of readiness fregulatory agency
inspections
·?????? Manage material quality management related to solid products.
·?????? Execute the business process management (BPM) of event CAPA.
? Be in charge of Deviation periodic review to seek continuous improvement
opportunities
6 Other quality related activities
·?????? Support to draft review the local product APQR.
·?????? Involve support the inspection by HA Roche Global inspection.
·?????? Involve quality related projects.
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7 Complete other tasks assigned by senileaders
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Qualification Experience
Education/Qualifications
·?????? BachelDegree (4 years education of Pharmacy, Pharmaceutical,
bioengineering, Chemistry equivalent education level)
·?????? Graduate higher-level Degree is preferred
Job Required Competencies
·?????? Experience (may vary depending on site size/scope)
? 5 more years’ work experience in the pharmaceutical related industry
? 3 more years’ experience in a commercially licensed GMP facility
·?????? Knowledge/Skills/Competencies
? Professional knowledge of Quality System QA principles, practices
standards fthe pharmaceutical industry
? Rich knowledge of cGMP relevant to the pharmaceutical industry
? Knowledge of pharmaceutical, biotechnology medical device related product
operations including local international quality regulations.
? Project management skills
? Demonstrate good verbal written communication skills in English
? Focus on value customer
? Learn fthe future
我們是誰
打造更健康的未來是促使我們創新的動力。全球超過100,000名員工共同致力于推進科學，確保今天和明天的人們，都能獲得高質量的醫療資源。我們的努力幫助了2600多萬人使用我們的藥物進行治療，我們的診斷產品運行超過300億次檢測。羅氏通過賦能探索新的可能、激發創造力并保持高標準以提供突破傳統的醫療解決方案，對全球的醫療環境帶去推動和影響。?
讓我們一起，構建更健康的未來。
羅氏提供平等的職業發展機會。