南京招聘

职位描述：
Position Description:
As the central quality contact for the Elanco Marketing Affiliate organization, the QUALITY MANAGER advises, decides reports, consults and escalates quality matters relating to Elanco products distributed in China , to the appropriate affiliate management, Senior Region Quality Manager, Regional Quality Leader or Corporate management when needed.
Functions, Duties, Tasks:

CORE JOB TASKS
? Be responsible for product quality related matters, escalate any local product quality related issue to the Senior Region Quality Manager, Regional Quality Leader and the affiliate management, and collaborate in any local action to be taken as a result of that (i.e. recall, counterfeit etc.)
? Implement and monitor product quality systems and Quality Manual in the Marketing affiliate.
? Assist affiliate management, Senior Region Quality Manager, Regional Quality Leader in assuring that all operations of the affiliate comply with the Affiliate Quality Manual and other applicable company quality standards, GQP and local regulations.
? Execute the assessment plan for GMP Service Providers.
? Create and revise Quality agreements covering affiliate processes for GMP service providers.
? Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.

SPECIFIC AREAS OF ACCOUNTABILITY / RESPONSIBILITY
1. Quality Management
? Ensure affiliate compliance with Good Manufacturing Practices (cGMP), Good Warehousing practices, GQP and good Local testing practices for finished products. Also ensure affiliate compliance with all relevant local regulations.
? Conduct quarterly trends (events, complaints, approvals).
? Ensure an annual management review is conducted.
? Ensure Notification to Management within one day of identification.
? Halt, hold or quarantine product status as required.


Batch Release
? Ensure products received comply with the market authorization, by approving/rejecting batches.
? Where QC testing of API (Active Pharmaceutical Ingredient) is a local regulatory requirement, ensure Good Manufacturing Practices (GMP) is followed

Change and Event Management
? Create, execute and close change controls that may affect the quality attributes of the product. Assist with management of the change control system.
? Create and resolve deviations (events) from normal procedures that could potentially impact safety, identity, strength and quality of the product. Ensure deviation completion is within requirements and corrective and preventative actions are completed by target date.

Documentation
? Maintain local procedures which reflect local regulations (where required) and corresponding global quality standards.
? Create or review relevant quality related documents.
? Ensure record retention of documentation as per appropriate record retention period.

Personnel Qualifications
? Maintain a job description and CV that describes the quality duties and review it every two years.
? Review, and approve GMP, GQP training material generated by the local affiliate and ensure training records are documented

Quality Plan
? Develop and execute the Quality plan to correct and prevent recurrence of significant quality problems from audits, self-inspections, deviations, recalls, product complaints or significant changes
? Ensure compliance to the Affiliate Quality Manual, other applicable company quality standards, GQP and relevant local regulations by completing quality system maintenance activities by target due dates
? Adhere to and meet Quality plan actions target due dates.

Auditing and Inspections
? Conduct self-assessments of quality systems at least annually, to maintain a state of inspection readiness at the affiliate.
? Assess GMP suppliers and service providers where applicable according to an approved plan.

Regulatory Interactions with Government Agencies
? Provide information required for reporting to global management such as but not limited to site notification of a regulatory inspection (announced and unannounced), requests for regulatory responses to product quality related matters, agency requests for samples (raw materials, intermediates, active pharmaceutical ingredient or drug product) and communications of potential restriction on product supply to management and regulatory agencies
? Participate in communications to the regulatory agencies on a product quality related matter.

Adverse Events and Product Complaints
? Ensure a process is in place to report adverse events and product complaints as per Elanco Quality standard and local regulations
? Ensure a process is in place to manage product complaints, data collection, assessment, action, notifications, closure within required timelines, trending and record retention.
? Investigate product complaints as required to ensure closure within required timelines.
? Provide quality oversight of call centers to ensure the quality system is maintained in a compliant way and reporting requirements are met.
? Ensure timely response to customers if necessary
? Represent product complaints in Marketing Affiliate inspections as needed

Materials Management
? Ensure a system is in place to manage the handling, accountability and traceability of inventory including free goods in accordance with local regulations and label storage conditions
? Ensure Quality approval of promotional items that have a potential to impact the product quality or safety of the customer and/or animal
? Request in consultation with the Senior Region Quality Manager and Regional Quality Leader, approval from the Global Quality Leader of the decision making process for redistribution of any rejected, recalled and counterfeit product

Distribution of Finished Products
? Ensure product shipped from one marketing affiliate to another meets the marketing authorization of receiving country.
? Consult on operating temperature and humidity (where applicable) ranges for storage areas
? Ensure inventory cycle counts are performed annually.
? Investigate significant confirmed cycle count discrepancies using the deviation process. Consult with the Senior Region Quality Manager and gain approval on adjustments outside of accepted tolerances


Minimum Qualification (education, experience and/or training, required certifications):
Skills:
? PC Skills – Microsoft; SAP, Word, Excel, and Outlook
? Analytical/investigational skills
? Inventory management knowledge highly regarded.

Attributes:
? Attention to detail
? Customer Focus
? Excellent interpersonal and communication (written and oral) skills
? Strong organization and planning skills
? Ability to prioritize and manage competing tasks and timelines
? Self-managed
? Teamwork skills

Experience:
At least 5 years Quality experience in a GMP/GSP environment.

Qualifications:
? Tertiary qualifications in Science or related field
? Registered Pharmacist (if required by local laws) 举报 分享

美国礼来制药（eli lilly and company）是一家全球性的以研发为基础的医药公司，创立于1876年，总部位于美国印地安那州印第安纳波利斯市，业务遍及全球 125 个国家和地区。礼来致力于为全人类提供以药物为基础的创新医疗保健方案，使人们生活得更长久、更健康、更有活力。

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礼来中国的员工价值主张是“享你未来”！具体到整体回报的四个方面，礼来中国分别倡导业享所得、家享关怀、才享卓越、心享悦然。

薪酬方面我们倡导业享所得。每一份努力，都让梦想离得更近。承担的职责越多，绩效越优秀，获得的薪酬回报也越高。

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个人发展方面我们倡导才享卓越。每一步成长，都有平台助力腾飞。我们致力于为每位员工提供全面的职业发展支持，助你成为令人艳羡的业界精英。

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如果你一直想加入这家有着良好声誉的公司， 现在， 机会之门正在敞开！我们寻求优秀的你， 自信的你加入我们， 和礼来一起共同成长。无论你是经验丰富的专业人士， 还是胸怀壮志的应届毕业生，相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧，加入我们， 礼来将助你成就梦想！

详细信息请查阅礼来中国招聘官方网站http://www.lillychina.com/careers