锦鲤求职岗位描述
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
Product Release & Batch Documentation Management
Batch Record Review: Lead the comprehensive review and approval of all Batch Production Records (BPR) and Batch Control Records (BCR) to ensure completeness, accuracy, and strict adherence to cGMP standards.
Release Decision & Certification: Facilitate the efficient and timely release of products by verifying all testing results against specifications and issuing Certificates of Analysis (CoA) for final batch disposition.
Aseptic Oversight: Oversee the local batch release process specifically for aseptic filling and packaging operations, ensuring that sterility assurance and environmental monitoring data support the release.
Materials Management & Supplier Quality
Material Disposition: Manage the quality oversight of raw materials, consumables, and primary packaging materials, ensuring they are sampled, tested, and released on-time to support production schedules.
Perform thorough risk assessments to identify potential quality risks, develop and implement risk mitigation strategies
Supplier Lifecycle Management: Lead the quality evaluation and qualification of material suppliers based on risk-based quality criteria and international regulatory requirements.
Service Provider & Third-Party Oversight
External Service Governance: Manage the quality oversight of third-party service providers and external laboratories, ensuring that outsourced testing and GMP-related services (e.g., calibration, validation) meet internal quality standards.
Quality Agreements: Drive the establishment and maintenance of Quality Agreements with service providers and third-party labs to clearly define compliance responsibilities.
Audit & Inspection Readiness: Collaborate and lead during internal/external audits and Health Authority (HA) inspections, representing the quality status of supplier and service provider management systems.
Annual Product Quality Review (APQR) & Quality Trend Analysis
APQR Compilation & Coordination: Lead the end-to-end preparation, coordination, and compilation of the Annual Product Quality Review (APQR) to evaluate the consistency of existing manufacturing processes and the appropriateness of current specifications.
Data Synthesis & Statistical Analysis: Systematically review and analyze critical data, including batch records, out-of-specification (OOS) results, deviations, changes, and stability data, utilizing statistical tools to identify any adverse trends.
Compliance Assessment: Evaluate the effectiveness of corrective and preventive actions (CAPAs) and previous year’s recommendations to ensure continuous improvement in product quality and process robustness.
Regulatory Reporting: Ensure the timely completion and archival of APQR reports in compliance with global regulatory requirements (e.g., NMPA, FDA, EMA), and present key findings during Quality Management Reviews or health authority inspections.
Responsible for ensuring that product quality issues are correctly investigated, and that appropriate corrective and preventative actions are implemented. Review deviation/exception/ investigation reports.
Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
Maintain project timelines associated with initiatives to support the evolving business.
Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
Support the compliance, regulatory and training activities as required,
Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QA operations.
Other related duties as assigned.
Qualification and Experience 能力与经验
Education/Qualifications
The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.
Certification and trainings such as auditor training will be advantageous.
Leadership Competencies
Models Integrity
Focus on value and customer
Align for success
Deliver results
Learn for the future
Job Required Competencies
A minimum experience of 7 years in pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
Aseptic Filling experience is required and experience in the new DP facility project is expected.
FDA/EU cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international regulatory network.
Able to logically solve problems in order to find timely solutions.
An ability to interact and communicate with all types of personalities in an effective and diplomatic manner
Good decision-making capability
Experienced in new facility startup readiness and operation ramp up
Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders
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。