pe jobs (salary & requirements)

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
Principle Roles & Responsibilities / Accountabilities主要职责/责任
Quality Technical Guidance

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Works with the management team to support the development oversight of robust quality systems, including both implementation operation at site level.
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Supports the site level Quality Management Review (QMR) program including monitoring reporting key performance indicators, as appropriate.
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Review systems analyze data (paper electronic) to identify specific compliance data consistency issues.
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Implements executes the Inspection Readiness program; including Roche Corporate Inspections Health Authority Inspections, which includes site inspection preparation, program management, response commitment process.
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Facilitates training on all GMP & Quality Compliance programs.
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Support the continuous improvement oversight of Quality System Compliance programs identifies implements new technologies to improve the compliance efficiency of QS operations.
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Collaborate with project, F&E, MSAT, manufacturing, QC teams to address quality issues.
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Other related duties as assigned.

Education/Qualifications

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The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, a related discipline.
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Certification training such as audittraining will be advantageous.

Job Required Competencies

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A minimum experience of 2 years in pharmaceutical biotechnology in quality assurance,including Data Integrity (ALCOA+) compliance, self-inspections, ideally in a multinational company.
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Experience supporting cGMP manufacturing operations through administration enforcement of the Quality Management System.
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Ability to apply a phase appropriate, risk-based approach to QA operational decisions.
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Aseptic Filling experience is required experience in the new DP facility project is expected.
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FDA/EU cGMP know-how understanding of ICH guidelines, with exposure to the international regulatory network is preferred
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Able to logically solve problems inder to find timely solutions.
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Ability to work well independently within a team.
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Strong follow-upganizational skills.
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***********3Fluental written communication skills in English with technical writing experience required.
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Project management skills are preferred.

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。