Formulations Technical Facilitator社

面议

无锡市本科及以上7年及以上

发布时间：2023-09-06

职位描述

Responsibility:
？Design qualification/validation and conduct qualification/validation activities based on risk assessment and statistics approach, incl. URS, RTM, Validation plan, validation design and execution, etc.,
？Manage qualification and validation related change activities, e.g., supply switch over management, validation batches release management, etc.,
？Investigate issues encountered during routine production; provide the technical evaluations and studies (e.g. DOE) to drive process robustness.
？Take product and process ownership to conduct CPV, identify improvement opportunities, address the risks, and take proactive actions.
？Work with internal and external stakeholders, e.g., quality, supply chain, manufacturing, M&ST, Ops Regulatory, China RA, etc., to manage technical related affairs, such as GCE, CMC variation projects, etc.,
？Act as the process and regulatory experts to coach quality, technical and manufacturing team to uplift capabilities.
？Author technical related SOP, WI, BRP, EBR, Technical Reports, Validation documents, etc.,
？SAP master date maintain
？Author technical training materials and manage product knowledge
？Lead or support technical project deliverables on time in full, and compliance with AZ PMF, e.g., CMC variation, TT and continuous improvement.
？Provide GMBR/PVL/PMBR related training to MBR authors and maintain PAS-X related skill matrix; Review PAS-X authorization application for operators and MBR authors at BAU stage, and maintain the role mapping;
？Continuous improvement of PAS-X related process, such as GMBR/PVL/PMBR change management, test management etc.
？Build and maintain networking globally and manage relationship with global key stakeholders
？Manage GMBR/PVL/PMBR change, coordinate test and track the change; Provide technical service for MBR authors; Ensure GMBR change comply with AZ global standard, and drive continuous improvement of GMBR/PVL/PMBR
？Compliance & SHE
？
Requirements:
？University graduate or above
？At least 7 years’ experience in pharmaceutical process
？Professionalism in the Pharmaceutical knowledge and experience; including production processes, validation, trouble shooting, investigation, and continuous improvement
？Knowledge of specific dosage forms.
？Oral Solid Dosage knowledge required for formulation process facilitator;
？sterile/aseptic process and microbiology knowledge required for sterile process facilitator;
？Blister & bottle packing, etc. knowledge required for packing process facilitator;
？GMP and regulatory knowledge
Experience in PM or Technical Supports of CMC variation and TT

其他要求

招聘人数：1人
职能类别：其他生物工程

公司介绍

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