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
1. Primary Purpose of Job (Job Summary)
Roche is hiring fa greenfield facility in Shanghai we are looking fan Associate Manager who has strong execution skills experiences to actively support the manager in establishing operations. Collaborate closely with the project team to execute this strategic initiative—including facility design, qualification, manufacturing readiness start-up. Additionally the role will oversee daily operations to ensure long-term success, while fostering developing his teams.
The Packaging Associate Manager is responsible fachieving manufacturing goals providing leadership oversight to all routine operational administrative activities which occur within the process step i.e. Needle Cutting Visual Check, Labelling Packaging. Ensuring products are executed safely timely in full compliance consistency with GMP/ SHE requirements Roche’s corporate principles, quality policies standards.
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Enable empower your team to achieve our vision by leveraging creative leadership competencies exemplifying the Leadership Commitments.
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The role plays a critical part in strategic project realization including facility design, qualification manufacturing readiness start up.
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The role leads to establishing a solid foundation in packaging production while demonstrating strong on-site execution skills, problem-solving abilities to ensure efficient, compliant, quality-standard operations.
2. Principle Roles & Responsibilities / Accountabilities
Leadership & People Management
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Build retain an inclusive workforce foster an environment where diversity of thought perspective are valued.
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1313Maintain an inclusive team that values diversity of thought.
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Maintain strong partnerships with leaders to ensure alignment on strategic projects daily operations.
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Take the responsibility fdepartment daily SHE management, implement site SHE procedure program, achieve site corporate /site SHE KPI. Promote SHE culture improve employee safety behavior.
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1313Manage performance development team members to achieveganizational goals employee personal professional growth.
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1313Support manager to build a strong pipeline of talent robust succession plans fkey positions.
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13131313Maintain a culture of continuous improvement model lean leadership principles
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Maintain a culture of transparent, high performance, empowerment innovation culture.
Technical
Engineering Project Support Operation Readiness:
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Participate in new facility design construction, including but not limited to process design, equipment selection, URS review, FAT, SAT, IOPQ etc. to contribute to project delivery.
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As a key role, support to establish an effective operation system in alignment with the Roche’s standards, including manufacturing system, CCS strategy, people training qualification system.
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Participate in CCS strategy implementation in operation to ensure preventing mix-up.
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Ensure teams competencies in performing the following tasks: e.g. Needle Cutting Visual Check, Labelling Packaging.
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Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
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Perform other duties as assigned.
Routine Operation:
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Ensure routine operation in compliance with regulations achieve high-quality production standards.
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Ensure total readiness of manufacturing suites, including housekeeping, machine, materials, documents other resources to ensure product delivery in time within budget.
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Arrange the packaging shifts in routine production, participate in operation as a packaging SME perform daily review of production batch record, deviation according to schedule.
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Lead to execute operators’ qualification, provide on-the-job training to support formalized technical GMP training.
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Oversee the daily operation, monitoring, maintenance of packaging equipment to ensure compliance with procedures.
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Supervise packaging operations during production intervene promptly in case of abnormalities.
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Participate in the response of regulataudit global quality audit as SME during regulatory inspections audits.
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Raise deviation involve the root cause investigation, including appropriate escalation where needed to ensure closure of deviation within the set timeline.
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Raise change control provide assessment.
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Execute regular validation activities, such as process validation, cleaning validation, equipment qualification system validation.
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Participate in Operational Excellence Continuous Improvement initiatives.
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Related IT system operations, such as SAP, MES, Veeva, Cornerstone.
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Perform other duties as assigned.
3. Qualification Experience
Education/Qualifications
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College’s Degree (Pharmaceutical / Biological is preferred) above.
Job Required Competencies
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10 more years’ operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred.
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3 more years’ people management experience.
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Experienced in strategic projects of Labelling Packaging facility including design, commissioning & qualification is preferred.
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Strong knowledge of cGMP regulations relevant to the pharmaceutical industry, especially in the biological industry.
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Fluent communications skills in English is preferred the ability to effectively communicate, collaborate, foster positive interactions with team members stakeholders.
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。
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