北京招聘

职位描述：
工作职责：
Role Description
The successful candidate will provide strategic and tactical support to the managers and professionals in all of the following areas: current GMPs, RegulatoryCMC, deviation investigations, lot release, regulatory audits, change management, and contemporary product and process validation. Will enable quality strategy and drive changes to support manufacturing product transfers associated with the site. The candidate will also maintain appropriate contacts to access additional information in regards to the overall pharmaceutical compliance landscape. Will assure that validation procedures and practices are aligned with Pfizer Quality Standards (PQS). This position leads a team of managers and individual contributor direct reports with a wide range of quality compliance responsibilities within validation and change management.

Responsibilities
The responsibilities include but are not limited to:
Tech Transfer: Support every product and transfer project at the site. These projects arise from many separate processes, including continuous improvement projects, and business. The incumbent will develop close communication channels with each of these various project sources.

Product and Process Validation: Support all product and process validation and equipment qualification at the site while following industry contemporary and Pfizer Quality Standards. Develop and maintain a Site Validation Master Plan and a Periodic Review program.

Audits and Inspections: Organize and lead the support of regulatory and internal audits as they relate to Validation and Change Management Program. SME for validation related topics during regulatory inspections, develop responses to potential findings, and assure timely completion of corrective actions and commitments.

Site Change Management Program: Responsible to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings. Review and approve all proposed changes impacting finished products, equipment, processes and facilities.

Cleaning Validation: Ensure that all cleaning processes are qualified, and those products processes of being enhanced are validated appropriately. Develop and maintain a Cleaning Validation Master Plan.

Equipment Qualification: Support all product and process validation and equipment qualification at the site while following industry contemporary and Pfizer Quality Standards. Develop and maintain a Site Validation Master Plan and a Periodic Review program.

This position is responsible to maintain the structure to ensure that all internal and regulatory commitments and timelines are tracked and met. In addition, resource projections and budget preparations are expected. Also responsible to provide or oversee the preparation of project cost estimates, and will provide support and GMP review for major site capital projects.

Responsible for the development, mentoring, and performance management of a team, professionals, and technicians. Fostering a culture where innovation, science and risk-based quality and colleague engagement thrive, framed within the Pfizer Values

任职资格：
Qualifications
Education and Experience:
BSMS or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and minimum of 10 years of related experience. Previous experience as a manager of colleagues is required and experience leading first line supervisors and managers are preferred.

The candidate should have experience in at least several of the following: cGMPs, Regulatory (worldwide), deviation investigation, drug product lot release, GMP Audit support, technical product transfers, change control management, equipment qualification, cleaning validation, computerized systems validation, and product and process validation.

Technical Skills:
A robust working comprehension of the theory and function of pharmaceutical equipment and systems is required. These may include sterilizers, depryrogenation ovens, washers, WFI, HVAC systems, aseptic filling equipment, incubatorsrefrigerators, cleaning equipment, inspection equipment, assembly equipment, labelingpackaging equipment, data recorders and personal computers. Knowledge of contemporary validation guidelines for pharmaceutical industry.

Ability to read, analyze and interpret common scientific and technical journals, financial reports (as needed), and legal documents; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; respond to regulatory agencies; and respond to complaints from customers.

Ability to define problems, collect data, establish facts, and draw valid conclusion; interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract or concrete variables. Ability to gather and analyze information skillfully and present in many forms.

Should have the ability to perform advanced mathematical concepts such as exponents, logarithms, quadratic equations (as needed), and apply mathematical operations to such tasks such as frequency distribution, CpK, determination of test reliability.

The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.

The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.

To perform this job successfully, an individual should have an advanced knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects).

Written Communication
Writes clearly and informatively, strong technical writing skills are essential; presents numerical data effectively.

OralWritten Communication
Listens carefully and gets clarification; able to express complex ideas in a clear, concise manner; capable of explaining technical issues to non-technical personnel. Writes clearly and informatively.

Deliver Results
*Demonstrates Business Acumen
*Acts Decisively
*Seizes Accountability
Individual commitments and business unit goals are aligned to strategy, prioritized to business impact as defined by clear measures of success. Colleagues are inspired and focused on outcomes and results that achieve our organization's purpose. Performance standards and metrics are in place, commonly understood and reinforced.

Engage Today's Talent & Build the Next Generation
*Holds People Accountable
*Builds Effective Teams
*Self-Awareness
*Grows Others
Colleagues understand they are accountable for outcomes and are empowered to deliver upon commitments. They recognize the business benefits of diversity and inclusion, and this environment is openly fostered. Colleagues belong to a diverse team, capable of performance, developing for future business needs and engaged to do their best work. Talent is identified and developed, mapped to future business needs, with people supported in their careers and building networks across the business.

Shape The Future
*Commits to ”One Pfizer”
*Leads Change
Individual must have a thorough understanding of current industry regulatory and Pfizer requirements in this field as well as industry trends. Colleagues and team are diverse, adaptable in the face of change, have the ability to identify opportunities and the desire to capitalize on them. The Pfizer values underpin every decision and action. Stakeholders are appropriately involved in decisions that affect them. Climate is a tangible subset of organizational culture where managers have a key role in shaping and transforming.

PHYSICALMENTAL REQUIREMENTS
While performing the duties of this job, the employee is occasionally exposed to general laboratory andor manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift andor move up to 25 pounds; specific vision abilities required by this job include ability to adjust focus.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site 举报 分享

大连工厂是辉瑞制药有限公司在大连开发区的生产基地，也是辉瑞全球生产集团(PGM)在中国的一个区域性供应组织。工厂占地面积82,000平方米，其中厂房设施占地20,586平方米。大连工厂拥有世界上最先进的生产设施和检测技术。产品包括多种片剂、粉针剂、粉剂和胶囊等多种剂型的制剂药。工厂率先于1997年4月获得国家GMP认证委员会颁发的中华人民共和国第0001号GMP认证证书，其综合生产能力已居国内领先水平。由于工厂拥有世界一流的检测分析手段和辉瑞全球统一的完善的质量保障体系，使工厂的产品全部达到或者超过了中国药典和美国药典标准。此外，大连工厂的产品还分别于1994年、1997年、2000年和2002年通过了澳大利亚TGA检验，已获准出口日本、澳大利亚、菲律宾、巴基斯坦及欧洲等地。并于2004年4月获得由德国莱茵认证公司颁发的ISO14001环境管理体系认证证书，同时获得了中国国家认证机构认可委员会的认可。

作为辉瑞全球生产集团的一部分，大连工厂一直致力于生产高质量的创新药品，百分之百地满足客户的需求。同时，不断改进和创新，努力降低生产成本，创造并保持其在本行业内最优异的环保、健康和安全方面的业绩。