莆田招聘

工作职责:

POSITION RESPONSIBILITIES

1.Resolution of Product Quality Compliance Issues

1.1 Deviation Management

Ensure any investigations, out-of-specifications, change controls, complaints and any other quality related matter throughout the production from all associated manufacturing sites is closed

Execute review and ensure any associated deviation is managed and closed within Pfizer’s QMS

Ensure any changes that may require a variation to marketing authorization, manufacturing license or GMP clearance are notified to management as per Pfizer’s procedures

          

1.2 Product Complaint handling

Intake and triage where they classify the complaint and forward to site for investigation of its expedited

Notification of Expedited Complaints to Local and Global Management colleagues

Receipt and assessment of the complaint sample

Forwarding of complaint to relevant plant or technical assessment of complaint

Preparation of product complaint investigation package

Tracking and follow up of investigation

Technical evaluation of investigation data and reports

Follow up and review of corrective and/or preventative actions

Escalate complaint trends to Management

2.Notification to Management

Informs SCQ Greater China Cluster Lead of significant deviations, as well as any issues impacting marketed product

Follow up local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions

3. Product Quality System

Confirm GSOP compliance, completion of gap analysis reports and training.

Monitor local quality performance (metrics) and identify and implement actions upon discovery of trends/issues and share with all relevant local stakeholders

Assess any new or updated regulatory requirements and implement  

Participate in trouble shooting investigations

Participate in Continuous Improvement for processes and systems

Assist in writing Area-Quality Review Team (A-QRT/ SQRT) reports and participate in meetings

Participate in Market Action / Product Recalls

4. Local Product Disposition

Review Certificate of Analysis, COC and any other relevant information, of fully finished products

Review packaging artwork of fully finished products

Conduct transactions in Systems, Applications and Products (SAP)

Oversight of returned goods and Reprocessing

Ensure effective and efficient local batch release

Assess temperature excursions, using available data or plant support and provide batch disposition

Coordinate regular quality review meetings with the distribution warehouse quality unit

Liaise with External Supply Quality (ESQ) and the manufacturing site to determine disposition of product which have experienced a temperature excursion

Ensure that a system is in place to manage

Ensure that records are made and maintained for inspections is undertaken in accordance with and assessed against appropriate specifications

Prepare and report on Key Performance Indicators and departmental activities in monthly management reports, S&OP meetings

5. Inspections and Internal Audit

Lead preparation for and co-ordination of GMP/GSP/MAH related inspections by Regulatory Authorities or Pfizer internal auditors

Prepare and agree with SCQ manager and applicable colleagues on responses an action plans to address issues identified during regulatory inspections or Pfizer internal audits

Prepare Self inspection plan for the year and ensures the plan is met

Track the implementation of the identified actions within agreed timeframes

6. Local Contractor Quality Oversight   

Ensure effective quality oversight of local contractors (Logistic Service Providers, re-packers and brokers)

Ensure quality agreements are maintained and reflect current requirements

Review quality performance and agree action plans to ensure continuous improvement

Communicate critical and major regulatory inspection observations and MSQA audit findings to SCQ Greater China Cluster Lead and provide input into CAPA plans

Provide Quality Due Diligence for local contractors and ensure CAPAs can be addressed and closed in a timely manner

7.  Quarantine Alert Notices (where non-Pfizer warehouses are used to receive and store product in the country)

Ensure that Quarantine Alert Notices received are processed in a timely manner

8.  Commitment Tracking

Ensure Regulatory, Internal Audit and AQRT commitments are completed as required

9. Change Control

Ensure all changes are appropriately documented and approved as required

10. Market Actions

Support local market action team and ensure effective completion of all required actions

Responsible to establish appropriate service level agreements, performance requirements, monitoring metrics and issue management with local, regional or global teams that provide data and information systems services to the market

Lead or participate in various continuous improvement strategies and projects and own role appropriate projects

Manage and maintain the integrity of portfolio data and associated documentation

Manage coordination of key stakeholders locally, internationally and across cross-functional teams

任职资格:

EducationsBachelor degree in Pharmacy, Chemistry, Biology, Microbiology, Biochemistry, Engineering or similar related disciplines

EXPERIENCE A minimum of 5-6 years previous experience is required

Demonstrated ability to influence other work partner

Able to operate independently in ambiguous situations

Self-motivated individual who is comfortable with working independently

Strong communication and interpersonal skills

Good English skill in oral & written

Licensed Pharmacist is prefer

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.