Associate Manager / Senior Specialist - Quality Assurance

在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。

职位

1.1 Quality Oversight

Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in repackaging products and IMP materials life cycle and the E2E process.

As per the business arrangement, the scope of quality oversight should cover the quality activities in all related areas including warehouse operation and packaging plants.

Manage and oversee frontline QA activities of repackaging products and IMP products in plants.

Manage of sampling process for repackaged products

Perform oversight of Specification, process and product monitoring for repackaging products

Perform oversight of stability program for repackaging products

Connection with Global, take role as quality role across the repackaging product life-cycle management.

Execution of frontline QA activities in plants and warehouse

Acknowledge the live status in production area according to the DPS and follow up with actual excursions against the DPS, identify the potential risks and take preventive action.

Join Tier meeting in production and warehouse or other Tier meetings

Perform batch record review

Enabling real-time problem solving with production and warehouse team

1.2 Implement repackaging and additional labeling IMP product-related batch release process

Ensure on-time batch documentation review per the requirement of Roche Timeline.

Ensure products are not sold or supplied before a QP/AP has released, each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevant

Additional labeling IMP batch release.

1.3 Execution of direct/ IMPmaterials management

Ensure on-time direct material batch disposition per Roche requirement

Implement oversight of material quality including Specifications, Artwork, SAP/MES master data, Change, DMS/CAPA, new material qualification, quality management etc.

Support local supplier quality management including audit, Quality Agreement etc.

Clinical trial material shipping documents check and system release

Temperature excursion evaluation during transportation for local sourced IMPs.

Support the investigation of repackaging and IMP products complaints.

1.4 Coordination and handling for quality related issue

Implement the management of Event &CAPA：Be able to utilize RCA tools and can facilitate related departments to conduct discrepancy investigation, ensure the investigation completed within specified due date and supporting products release.

Collaborate with SMEs and Lead investigators to develop investigation strategies

Participate in Local Quality Council when needed

Monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time and keep continuous improvement

Handle Customer complaint:

Perform customer complaint investigation and ensure effective corrective and preventive actions are initiated and executed on time

1.5 Quality system oversight

Execute QA process/documentation maintenance in a continuously compliant state and a continual state of readiness for regulatory agency inspections

Manage material quality management in site

Manage repackaging of finished products and labeling management for donation products.

1.6 Other quality related activities

Support to draft and review the local product APQR.

Involve and support the inspection by HA and Roche Global inspection.

Involve quality related projects.

Document management

1.7 Complete other tasks assigned by senior leaders

Key Interfaces

Manufacturing, Engineering, Local MSAT, Planning, Warehouse, Safety, Medical and Regulatory affairs

Other Quality Functions

QMS document owners/authors

Global Functions: Regulatory (PDR/PTR), PT Development, TPLs and GxP Supplier Management.

Education/Qualifications

Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level)

Graduate or higher-level Degree is preferred

Job Required Competencies

Good accountability of GMP understanding and implementing.

Knowledge and experience in production and quality management.

Well communication skill and good accountability of problem solving.

Demonstrate good verbal and written communication skills in English

Focus on value and customer

Learn for the future

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。