LOC QMS Manager, Pharma 上海

月薪：

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Job Purpose 岗位目的:The job exists within the commercial Rx Local Operating Companies to ensure that the mandated GSK Quality Management Systems requirements for commercial operating units are met. The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance. The job holder is expected?To take the lead in implementing and sustaining the QMS China CI Rx, including encouraging the Commercial Rx business to own quality activities in their day to day work.?To ensure that the QMS is implemented and sustained locally.?Establish a network of personnel to handle implementation of new and revised GQPs and GQMPs.?Accountable and this network collectively responsible, for implementing QMS requirements within the local quality system and supporting its continual improvement.Key Responsibilities主要岗位职责:1.Quality Strategy?Key market contact and responsible person for all QMS activity and issues, relating to the commercial business.?Assess and proactively create and implement a continuous improvement plan for the adoption of the principles and requirements of a Quality Management System into the commercial business, includes identifying, understanding and sharing appropriate information.?Heighten and promote quality and QMS awareness in the commercial business functions.?Engage and assist relevant stakeholders in understanding and generating appropriate systems, processes and policies, as required within defined areas of the business, in compliance with QMS principles.?Build strong relationships across the LOC Commercial Business functions and work with them to develop quality objectives that meet both business and regional quality objectives. Undertake relevant training forums to deliver QMS knowledge to relevant parts of the business enabling them to identify, incorporate and deliver on relevant quality objectives.?Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.?Develop a network to obtain local regulatory intelligence and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or GSK’s reputation.?Gain understanding of the high level business plans of the LOC as they potentially link to quality – ensure any quality activities are identified and defined in the annual quality plan.2.Quality Systems?Responsible for the ensuring a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the GSKCI Marketing Company.?Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies ,GMP, GSP and regulatory requirements by performing the following:oEnsure that all SOPs are in place, updated & training has been conducted across the business. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to SOPs, GQPs, and GQMPs as relevant.oPromote QMS management principles and seek continuous improvement of the processes.oReview, conduct impact assessments and implement any updates to QMS policies.?To undergo training in GQP 1101 and GQMP&G 1003 on Effective QMS Implementation.Responsible for the QMS (Quality Management System) and GSOP implementation and monitoring of compliance within the China LOC/ Marketing Company by:oEnsuring that all internal procedures and systems in use in the LOC are compliant to GSK QMS , Guide for Commercial Companies and local regulatory requirements, including (but not limited to)？QMS Structure, Content, Management and Deployment？Artwork process？Change Control (including regulatory change ensuring ongoing compliance to registered details)？Complaint handling, trending and escalation？Batch disposition？Product Quality Review？Risk Management？Q Plan generation and execution？Documentation system (SOPs)？Training？Distribution？Repacking？Management of Product Incidents and Recalls？Technical Terms of Supply？Auditing (Level 1&2)？Deviation Management？Corrective and Preventive Action?Monitoring and assessing quality systems by means of audit and self-inspection, and other forms of evaluation against GSK standards, GQPs, GMP and regulatory requirements:？Conducting self, cross functional audits？Reviewing internal audit findings with the aim of measuring the ongoing effectiveness of the in use implementation of the QMS.?Ensuring there is a QMS input into the main aspects of the LOC operations that influence product quality.?Manage the preparation and conduct of L3/L4 audits of the LOC.？Ensuring that all colleagues in the LOC are adequately trained on the procedures and processes that relate to QMS.？Ensure the QMS implementation is lean as well as compliant and activities are conducted to ensure sustainability by adopting the principles of OE.？To identify resource capable of performing gap analyses of LOC or global SOPs, Corporate Policies (as they apply to LOC Quality) and the QMS updates.？To ensure gap analyses are conducted.？To ensure risks associated with gaps are assessed.？To ensure action plans to address risks are established in accordance with GQMP 1003 specified timelines.？To escalate significant QMS risks and issues related to QMS implementation.？To provide regular reports on progress against gap closure action plan and ongoing QMS ‘in place’ and ‘in use’ performance, for LOC and Regional review.？To ensure training needs are assessed for target groups and plans for training are prepared for closed gaps and in advance of receipt of new or revised QMS documents.？To notify relevant LOC teams and other impacted target groups of new or revised QMS documents.？To act as the principle point of contact between the Central QMS Team and the LOC for effective communication of existing, new or revised QMS requirements.？To ensure a robust mechanism for sustaining conformance of the local quality system with QMS requirements has been established and remains effective.？To ensure local audit processes build in routine assessments of QMS ‘in place’ and ‘in use’ status.？To share and publicise achievements and QMS implementation successes, recognising and rewarding individuals and teams as appropriate.？Provide QMS advice on an ongoing basis, as required.？Promote safety awareness. To use the resources of the LOC to ensure compliance and efficient performance is maintained.?Maintain LSOP Training Curricular with function head and HR. Responsible for LSOP upload to Mylearning and run training report by monthly.Specialised Knowledge 专业知识:?breadth & depth across disciplines or functions; expertise in field required所需知识的宽度（跨学科），所需知识的深度 （特定学科）Education and Experience:?Successful completion of relevant tertiary qualifications – science degree?License pharmacist?Around 8-10 years or more experience within the Pharmaceutical / Consumer Healthcare industries, AND preferably in the capacity of a senior quality specialist or a manager?Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits?Strong knowledge of regulatory requirements pertaining to GMP/GDP?Good knowledge on effective quality documentation systemsEssential Skills and Abilities:?Good Professional written and oral communication skills in Chinese and English. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization?Ability to influence and motivate stakeholders at any level of the LOC organization?Analytical mind, good attention to detail and problem solving skills within a structured process?Good team player – works well in cross-functional teams?Good time management skills, with ability to multi-task and work under pressure?Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.?Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods?Flexible thinking – able to challenge and see views from different perspectives?Ability to self-motivate and be resilient and focused under pressure?Able to effectively enable and drive change across cross functional stakeholders?Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook 职能类别： 药品生产/质量管理

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