长沙招聘

JOB SUMMARY

The Medical Quality & Compliance Officer(MQCO) works in Medical Quality Compliance team in supporting the Medical Quality & Compliance Manager to work closely with in-country platform lines to promote the quality management, compliance, inspection readiness, training process improvement, and the oversight needed, to ensure the high quality performance of country medical operations.

KEY RESULT AREAS & JOB ACTIVITIES /TASKS

1) Medical-compliance related training

- Be responsible for Job role and training curricular assignment

· Process the ‘LARS’ on Power-2-Learn (P2L) for job role, local WIs and specific training curricular assignment, based on the confirmation from supervisor.

· Generate quarterly tracking form and confirm with relevant team leaders for the job role and training courses assignment.

· Ensure medical staff and targeted colleagues are assigned with appropriate job role(s), local WIs and training curriculum by P2L system and assure that the processes described in the SOP ADM02 and China WIs are followed.

- Be responsible for tracking compliance of medical related trainings

· Run P2L BO report at least monthly to check the training completion and ensure medical staff to archive the full compliance for P2L required trainings.

· Track the unmet requirement report monthly. If required training is not completed by the due date, conduct the follow-up and document the relevant records.

· Generate kinds of training analysis reports to give input for the medical related trainings and track training compliance as appropriate.

- Be responsible for providing the orientation and medical related training for new comers

· Disseminate instruction email to medical new comers, maintain the ‘new hire instruction’ document current and accurate with corporate policy, SOP and WI.

· Provide the orientation training and relevant documents for new comers of medical and medical partner team.

· Present the medical related trainings including the training of good documentation practices for the new comers of medical partner team.

- Be responsible for documentation management of medical-compliance related training

· Provide the support to conduct the medical-compliance related trainings.

· Manage the training documentation and maintain the training tracking form and folders.

2) Procedures Improvement

- Be responsible for administering local SOP, Working instruction (WI)/Local Working Practice (LWP) and ensure the required documents are appropriately documented according to SOP QMS04.

3) Inspections/Audits

- Support on the audit/inspection activities carried out by QA group/regulatory authority

· Distribute upcoming audit/inspection information locally as appropriate and maintain audit/inspection tracking form and management folder.

· Provide the support on the coordination with audits/inspection organized by audit/inspection groups (e.g. serve as point of contact (“Coordinator”) between PCO and audit/inspection groups, audit scheduling/ logistics, report distribution, communication of local processes, updates, communication of final results and follow-up the audit/inspection CAPAs)

- Be responsible for uploading the key inspection readiness documents (CVs, JDs, Org Charts and training documentation) of PCO Medical Department into the SharePoint site and ensure the most up-to-date version and correct documents are available in the Repository.

- Conduct the quality review and distribute the quality report for CVs, JDs, Org Charts and training documentation of medical staff at least twice per year and ensure the documents in full compliance with compliance plan.

4) Team Specific Responsibilities

- Provide support in administrative duties including scheduling group meetings, team activities and project execution.

- Interact with team personnel in support of the daily operation and on special project as needed.

- Assist with creation, maintenance and dissemination of presentations, reports and documents. Responsible for work related documentation management as appropriate.

- The MQCO may be required for certain project/task as decided by MQCM.

BACKGROUND REQUIREMENTS

1. Educational /Training

- Education: Bachelor degree is required, Master degree is preferred

2. Working Experiences

At least 2 year professional experience in Medical/Regulatory/R&D Dep. in pharmaceutical industry demonstrating the following:

- Thorough knowledge of ICH GCP and related local regulations

- Understanding of the processes and regulatory requirements associated with clinical development, regulatory, medical and safety operations

- A good sense of compliance to clinical guidelines, regulations and protocol

- Experience with assisting SOP and training implementation

3. Ability Functional

- Conscientious, good team player

- Must be independent, pro-active, self-motivated with strong organizational, interpersonal and communication skills

- Excellent follow-up skills

- Excellent verbal and written communication skills for interaction with manager and colleagues

- Proficient in both verbal and written Chinese and English

- Demonstrated proficiency with all software including Outlook, Word, Excel, and PowerPoint as well as internet applications with ability to learn new applications

4. Cultural Competencies (Leader Behaviors)

- Sustain Focus on Performance

- Create an Inclusive Environment

- Align Across Pfizer

收简历邮箱 pfizer_hr_north@pfizer.com

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.