QA Supervisor.doc

Job Summary：職位摘要：This position is responsible for the management of the companys Quality Assurance team and activities associated with all aspects of Quality Assurance related to systems, processes and procedures supporting the compliant introduction, manufacture & release of all products destined for ALL markets. The incumbent shall ensure (i) the Quality System complies with all relevant Regulatory requirements, (ii) our customers needs are fulfilled in a compliant manner and (iii) compliance / cost continuous improvement initiatives are successfully delivered, with appropriate education, coaching and mentoring, as necessary. 該職位負(fù)責(zé)管理公司的質(zhì)量保證團(tuán)隊及與質(zhì)量保證系統(tǒng)有關(guān)的各方面相聯(lián)系的活動，支持符合引進(jìn)、制造及放行所有市場的產(chǎn)品的流程和規(guī)程。質(zhì)量主管必須確保：（一）質(zhì)量體系與所有相關(guān)法規(guī)要求相符合。（二）從法規(guī)符合性的角度滿足客戶的需求。（三）必要時，通過適當(dāng)?shù)慕逃?，培?xùn)和指導(dǎo)使法規(guī)/成本不斷改進(jìn)創(chuàng)新。 This position reports to the Quality Assurance Manager. In the absence of the QA Supervisor, the QA Manager shall assume and deliver the responsibilities outline within this PD.該職位直接向質(zhì)量經(jīng)理匯報。當(dāng)質(zhì)量主管缺席時，質(zhì)量經(jīng)理需履行該職位內(nèi)的職責(zé)。Responsibilities / Daily Tasks: 職責(zé)/日常任務(wù)：1、Provide Technical Education, Coaching and / or Mentoring to the Quality Assurance Team and associated personnel with respect to:為小組質(zhì)量人員在以下方面提供技術(shù)教育，培訓(xùn)和指導(dǎo)：a)Regulatory compliance of all products manufactured within the TSI group to the requirements of the relevant market. 在XXX團(tuán)隊內(nèi)按相關(guān)市場的要求制造的所有產(chǎn)品的法規(guī)遵從情況。b)Regulatory compliance of all relevant Quality procedures to the requirements of relevant market. 相關(guān)市場的法規(guī)與所有質(zhì)量相關(guān)的規(guī)程的符合性。c)Operational understanding of current regulatory requirements, SFDA, FDA, IMB etc. and associated regulatory guidelines.對當(dāng)前相關(guān)的法規(guī)要求的理解，如SFDA，F(xiàn)DA，IMB及相關(guān)法規(guī)指南。d)Develop and effectively deploy an efficient training matrix for the Quality Assurance Team to appropriately support organizational requirements and personal development opportunities.制定和有效實(shí)施質(zhì)量保證團(tuán)隊的培訓(xùn)計劃，支持組織的需求和個人發(fā)展機(jī)會。2、Perform Operational Management of the Local & Remote Site Direct reports with the Quality Assurance Team:履行本部質(zhì)量保證小組和直接匯報的外地工廠質(zhì)量團(tuán)隊的運(yùn)作管理：a)Plan, organize, manage and monitor reports to achieve short & medium term business requirements.計劃，組織，管理和監(jiān)控報告，以實(shí)現(xiàn)短期和中期的業(yè)務(wù)需求。b)Actively participate with reports as appropriate in the Continuous Improvement initiatives aligned to organizational medium to long term goals.積極參與適當(dāng)?shù)牟粩嗤晟苿?chuàng)新，作為有計劃性的中長期目標(biāo)。c)Ensure all regulatory requirements are effectively communicated & supporting Quality System initiatives are successfully deployed locally & at all Remote Sites. 確保所有法規(guī)要求可以有效地溝通并支持質(zhì)量系統(tǒng)成功的創(chuàng)新包括本部和所有外地工廠。d)Assure compliance to all relevant SFDA, FDA, IMB etc. regulatory requirements through the Quality Assurance Team, including but not limited to:通過質(zhì)量保證團(tuán)隊確保符合所有相關(guān)的SFDA，F(xiàn)DA，IMB等法規(guī)要求。其中包括但不局限于：Auditing, 審計Systems Management Review, 系統(tǒng)管理評審Data Trending, 數(shù)據(jù)趨勢分析Compliance Schedule Review, e.g. Validation, Stability, 符合性計劃審查，例如：驗(yàn)證，穩(wěn)定性e)Consistently deliver role in alignment with organizational Vision, Goals and key priorities, namely:始終如一地與團(tuán)隊的長遠(yuǎn)目標(biāo)保持一致，目標(biāo)和關(guān)鍵的優(yōu)先事項，即：Quality, 質(zhì)量Customer Service, 客戶服務(wù)Delivery Performance, 貫徹履行Cost Effectiveness, 成本效益f)Create, manage and report QA Key Performance Indicators KPIs to improve operational performance of the Quality Assurance Team:創(chuàng)建，管理和報告質(zhì)量保證的關(guān)鍵績效指標(biāo)KPIs，以改善質(zhì)量保證小組的日常運(yùn)作：Compliance, 合規(guī)Speed, 速度Cost, 成本People Attendance, Training etc., 人員 - 考勤，培訓(xùn)等。3、Provide Senior QA input into organizational initiatives, problem solving and continuous improvement initiatives from a regulatory perspective, as necessary:從法規(guī)的角度提供高級質(zhì)量保證輸入到組織計劃，解決問題和持續(xù)改進(jìn)措施，必要時：a)Operational / Regulatory Issue Resolution, 行動/法規(guī)問題的解決b)Centralized Electronic Quality System, 電子質(zhì)量體系c)Improved Quality Efficiency & Effectiveness, 改進(jìn)質(zhì)量效率和成效4、Overall Management responsibility for the administration of the Various Documentation Systems, Customer Complaints / Customer Requests / Enquiries and GMP Agreements by the QA Officers.全面負(fù)責(zé)由QA專員負(fù)責(zé)的各個文件系統(tǒng)，客戶投訴/客戶請求/詢問等等。5、Establish and maintain effective professional relationships with SFDA, FDA, IMB etc. regulation representatives, such as International Sponsors, Auditors etc.和SFDA, FDA, IMB等法規(guī)機(jī)構(gòu)的國際主辦者、審計官員等建立并保持良好的關(guān)系。6、Perform other duties as assigned and you should be willing to perform short trips to domestic sites to assist in implementation of preventative actions / projects where required.執(zhí)行其他委任的職責(zé)，應(yīng)能適應(yīng)在國內(nèi)工廠之間短途出差以協(xié)助實(shí)施預(yù)防性措施或項目。Qualification：任職資格：1、Educational Degree：文化程度：Bachelors Degree (or above - preferred) in science / engineering or related scientific discipline with experience in operational Quality Systems in a regulated industry.在科學(xué)/工程或相關(guān)專業(yè)獲得學(xué)士學(xué)位（本科以上優(yōu)先考慮），在相關(guān)行業(yè)有質(zhì)量管理體系的經(jīng)驗(yàn)。Quality Management Certification preferred.有質(zhì)量管理體系認(rèn)證經(jīng)驗(yàn)優(yōu)先考慮。2、Working Experience：工作經(jīng)驗(yàn)：A minimum of 5 years technical experience in quality / technical management positions in highly regulated industries; Pharmaceutical / Complementary Medicines. 至少5年在醫(yī)藥/保健藥品行業(yè)中擔(dān)任質(zhì)量/技術(shù)職位工作。Management experience in the operational Quality Systems for Drug and / or Complementary Medicine products.具有藥物和/或保健藥品的質(zhì)量體系的管理經(jīng)驗(yàn)。Sound, in-depth knowledge of the principles of GMP & GLP and other relevant regulations applicable to Therapeutic Goods destined for Local and International markets. 深刻了解GMP和GLP及其他有關(guān)的本地或國際市場的藥品法規(guī)。Demonstrated success in the Designing, Planning and Execution of quality improvement projects / programs and associated tool application and KPI reporting.有在對質(zhì)量改進(jìn)工程/項目方面成功設(shè)計、計劃和執(zhí)行的經(jīng)驗(yàn)，相關(guān)工具應(yīng)用和KPI報告經(jīng)驗(yàn)。Proven experience in Change and Risk Management associated with Drug and / or Complementary Medicine products.具有相關(guān)藥物或保健醫(yī)學(xué)產(chǎn)品的變更和風(fēng)險評估的豐富經(jīng)驗(yàn)。Demonstrated skills in juggling challenging priorities, problem solving, planning, organising and decision making in highly regulated industries. 具有在高度管制的行業(yè)對復(fù)雜有挑戰(zhàn)性的事件解決問題、計劃、組織及決策能力。Strong analytical ability to quickly gather facts, draw conclusions associated with data and / or issues and present pragmatic solutions in a timely manner.具有高度的分析能力，能夠快速收集證據(jù)，匯同相關(guān)數(shù)據(jù)/問題給出結(jié)論并提出有實(shí)效的及時解決問題的方案。Good communication; written and verbal, and influencing / negotiation skills with internal teams, clients, and the industry regulators.良好的書面和口頭溝通技巧，良好的談判技巧