上海招聘

Validation Project Director - China

PSC Asia is seeking experienced project director(s) for regulatory compliance consulting services to support our growing sales activities in China. The candidates must have an outgoing personality with strong organizational, communication and interpersonal skills and the ability to work independently or as part of a team.

Job Responsibilities
? Managing and leading compliance remediation project in sterile injection manufacturing facility
? Job Responsibilities include supervision of project staff, commissioning and qualification staff.
? Providing compliance oversight in all areas (QA/QC, Operations, Production, Logistics, etc.) in cGMP facility for Sterile Injection Manufacturing.
? Acting as a subject matter expert on all process equipment and systems, instructing staff on commissioning, qualification and proper operation of equipment (e.g. bioreactors, chromatography systems, buffer/media preparation equipment, CIP/SIP systems, aseptic filling machines the automated controllers, etc.)
? Coordinating staff to generate, reviewing and approving cGMP documentation (Quality policies, SOPs, and all official documents) in all GMP areas.
? Hands on responsibility for commissioning of new systems and equipment, review of functional and detailed specifications, FATs/SATs, qualification, validation, deviation investigations and working with outside equipment/service providers.
? Acting as the point of contact between the client's management and the PSC project team.
? Maintaining project schedule, project budget and progress reports to the client.
? Ensuring proper site safety equipment is available for PSC and contract staff; and ensuring adequate safety equipment is available for PSC ad contract staff.
? Ensuring timesheets and expense reports are completed properly and submitted into PSC's time and expense systems.
? Mentoring junior staff members and interns.
? Conducting performance evaluation of project team members

Job Requirements
? Bachelor of Science degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering preferred) or Life Sciences degree.
? A minimum of ten (10) years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment, or the equivalent, is required.
? Strong project management experience is required.
? Prior work in maintaining GMP biotechnology and/or sterile process equipment is required.
? Excellent organization and project management skills.
? Proficient in computer skills and MS Office applications.
? Knowledge of process control systems (PLC, DCS and/or SCADA) is a plus.
? High energy and attention to detail.
? A demonstrated ability to work well in a team environment.
? Good leadership skills.
? Ability to work independently and as a part of a team, self-motivation, adaptability, and a positive attitude.
? Must be bilingual. Excellent written and spoken English and Chinese communication skills
? Well presented.
? Team player.

PSC生物技术(北京)有限责任公司在全球致力于推广和提升世界范围内医药和医疗器械行业的GMP水平，是全球高端GMP认证的引领者和传播者。 时至今日，美国医药服务有限已经成为全球首屈一指的专业化FDA、EMEA认证顾问公司，除美国洛杉矶总部外，相继在美国和世界其它城市成立分公司，以雄厚的技术力量覆盖全球，跻身成世界最具专业、最大的医疗行业咨询服务机构和原料药采购代理机构。公司从1996年成立至今，与北美、欧洲、亚洲的众多知名制剂企业建立了良好的合作关系，不仅为其旗下制剂、医疗器械产品提供验证及质量系统、国际认证、国际药政政策遵守等服务，更是囊括了产品进出口及采购和销售等多方面服务。

公司将为录用人才提供良好的职业培训，具有市场竞争力的薪酬福利待遇，有意者请发邮件至公司邮箱，并在Subject 栏注明应聘职位。


更多公司详情请参阅www.biotech.com或www.psc-asia.com

PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years.

PSC Biotech has over 358 customers in 23 different countries around the world. PSC Biotech is organized into three primary Business Units:
1. Professional Services
2. Life Sciences Software and IT (Enterprise)
3. Life Sciences Hardware (Equipment and Instruments)
PSC Biotech has offices in North America, Asia and the Middle East. We are the world's largest specialty biotech life sciences consultancy.

Company provides competitive compensation and benefits to hired employees.

Know more about PSC, please enter www.biotech.com / www.psc-asia.com.