職位描述
The Compliance Manager is responsible for Compliance functions to include: document control, regulatory compliance, internal audits, client audits, change control, complaints and personnel training records. This position requires the ability to manage and supervise employees and have good problem solving abilities. Must be able to interface effectively with internal personnel, clients, and auditors, including the FDA; prepare proper response to any observation as required on timely manner. This position is also responsible for all laboratory safety issues to include: safety training, safety audits of the laboratory, and disposal of chemical waste. Excellent communication (verbal & written) and customer services skills required. Excellent writing skills and experience writing technical documentation & reports required. Ability to simultaneously manage multiple tasks/priorities. Excellent problem solving skills/abilities. Good time management and negotiating skills required. Capacity for independent work required. Demonstrated ability to manage multiple projects and meet critical deadlines. Demonstrated ability to work in a team-oriented environment. Must have strong knowledge and experience in dealing with compliance issues in a pharmaceutical analytical laboratories. Will be required to assist with the preparation, execution, documentation, status updates and review of training sessions on a variety of department and regulatory topics. Other related duties as assigned. Must have good time management skills and able to perform to deadlines. Ensure that project milestones are met and documented. Ability to manage simultaneous tasks, work under pressure, track and monitor progress of multiple projects and follow through to goals. This position requires the ability to manage and supervise employees and have good problem solving abilities. Requires excellent troubleshooting ability, communication skills and ability to present data to clients and regulatory agencies. Requires a M.S. Degree in Science with at least 5+ years regulated documentation experience in the pharmaceutical industry. Experience in the contract testing laboratory industry preferred. 合規(guī)經(jīng)理負(fù)責(zé)合規(guī)功能包括:文檔管理、遵守規(guī)章制度、內(nèi)部審核、客戶審核,變化控制、投訴和人員培訓(xùn)記錄。這個(gè)職位需要的能力和督導(dǎo)員工的能力,有良好的解決問題的能力。必須能夠有效地與內(nèi)部人員，客戶,和審計(jì),包括FDA進(jìn)行交流;準(zhǔn)備適當(dāng)?shù)膽?yīng)對(duì)任何及時(shí)觀測(cè)的要求。這個(gè)職位還負(fù)責(zé)所有實(shí)驗(yàn)室安全問題包括:安全培訓(xùn),實(shí)驗(yàn)室安全審計(jì)和化學(xué)廢物的處理。優(yōu)秀的溝通(口頭和書面)和客戶服務(wù)技巧。優(yōu)秀的寫作技巧和經(jīng)驗(yàn)寫技術(shù)文檔和報(bào)告要求。能夠同時(shí)管理多個(gè)任務(wù)。優(yōu)秀的解決問題的技能/能力。良好的時(shí)間管理和談判技巧。有獨(dú)立工作的能力。管理多個(gè)項(xiàng)目的能力和滿足關(guān)鍵的最后期限。證明了在團(tuán)隊(duì)的環(huán)境中工作的能力。必須有很強(qiáng)的知識(shí)和經(jīng)驗(yàn)在實(shí)驗(yàn)室藥品分析問題上?？梢詤f(xié)助準(zhǔn)備、執(zhí)行、文檔、狀態(tài)更新和審查培訓(xùn)班各種部門和監(jiān)管的主題。其他相關(guān)職責(zé)分配。必須有良好的時(shí)間管理能力,能夠執(zhí)行期限。確保滿足項(xiàng)目里程碑和記錄。同時(shí)任務(wù)管理能力,在壓力下工作,跟蹤和監(jiān)控多個(gè)項(xiàng)目和完成目標(biāo)的進(jìn)展。這個(gè)職位需要的能力管理和督導(dǎo)員工的能力,有良好的解決問題的能力。需要良好的故障診斷能力、溝通技巧和能力展示數(shù)據(jù)給客戶和監(jiān)管機(jī)構(gòu)。需要科學(xué)碩士學(xué)位至少有5 +年制藥行業(yè)規(guī)范文檔的經(jīng)驗(yàn)。合同測(cè)試實(shí)驗(yàn)室行業(yè)經(jīng)驗(yàn)者優(yōu)先。職位概覽 為配合公司實(shí)驗(yàn)室建設(shè)及開展檢測(cè)業(yè)務(wù)，杭州艾品公司特此招聘以下各個(gè)部門的各類層次人員 (Technician, Associate, Supervisor, and/or Managers): Analytical Chemistry; Analytical Development; Stability; Biopharma; Microbiology; Quality Assurance; Business Development & Marketing; Finance; Human Resources; MIS; ICVS; Corporate Planning & Scheduling; Purchasing & Facilities;注意：成功應(yīng)聘者將由杭州艾品公司直接聘用并提供薪酬及福利待遇。所有雇員與長(zhǎng)三角綠色制藥協(xié)同創(chuàng)新中心或其協(xié)同成立單位（包括浙江工業(yè)大學(xué)）將無(wú)任何形式的勞務(wù)關(guān)系。聯(lián)系方式 Contact Info： 人事經(jīng)理 hr@irvinepharma-china.com 請(qǐng)按照下列格式書寫email主題：申請(qǐng)部門_職位_最高學(xué)歷_姓名。舉例，一位叫張三的申請(qǐng)者，最高學(xué)歷是碩士（MS），申請(qǐng)分析部門(Analytical Chemistry) 的HPLC Supervisor職位，則主題格式為：Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同時(shí)，請(qǐng)按照同樣規(guī)則將所附簡(jiǎn)歷命名。即其簡(jiǎn)歷命名為Analytical Chemistry_HPLC Supervisor_MS_Zhang San.If using email to forward resume, please follow the renaming rules below: Department_Position_Highest degree achieved_Last name First name. For example, an applicant named Zhang San wants to apply for the position of HPLC Supervisor in the department of Analytical Chemistry. The highest degree he had is M.S. Then please write email subject as Analytical Chemistry_HPLC Supervisor_MS_Zhang San. On the other hand, please rename the resume to Analytical Chemistry_HPLC Supervisor_MS_Zhang San as well.
