PQE中国现发布以下三个岗位的招聘信息，欢迎投递简历：
BUSINESS DEVELOPMENT MANAGER
CSV Consultant
GMP Consultant
PQE集团成立于1998年，是一家致力于生命科学行业的全球咨询公司，自2012年以来已在全球开设23家办事处，建立了国际化的网络。2003年3月以来，PQE集团已通过ISO 9001认证，目前在全球拥有700多名员工，在意大利、德国、西班牙、瑞士、比利时、波兰、俄罗斯、以色列、美国、墨西哥、巴西、厄瓜多尔、印度、中国和日本设有办事处。PQE集团致力于帮客户达成卓越的成本收益，同时保持最高的质量标准。
▌我们需要……
Business Development Manager
Education: Bachelor’s Degree
Business Development mentality: open-minded, organized mindset, self-starter, people person, eager, enthusiasm, result orientated and team player casual person
Fluent English for communication with International teams
Full availability to travel domestically and internationally (min 50% of working time)
Driving license, car owned, availability to drive
Able to work under pressure and stay resilient.
At least 5 years of experience in B2B Companies (nice to have IT companies; pharmaceutical industries)
Main tasks may involve Sales & Business Development
Support to Business Development Director
Excellent use of MS package (Word, Excel, Powerpoint)
Able to coordinating, supporting and organizing conventions, seminars or workshop
Preferable: working in western company culture or multinational companies
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Chinese: native -
English (B2/C1): mandatory
CSV Consultant
Location: Shanghai, China
Resolution of fundamental CSV compliance issues
Align with e‐Compliance on project management and life cycle documentation deliverables for GxP relevant projects
Ensure all project related risks are well managed and deliverables are validated (for GxP)/tested (for non‐GxP) in accordance to SOP and the associated CSV requirements
Ensure project team complies with the methodology and SOP and uses the correct tools
Ensure completeness and consistency of project life cycle documentation
Ensure all project related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
Prepare project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP
Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in document repository (Document Navigator) and approved in accordance to the prescribed SOP
At least 3 years of Computer System Validation or any validation experience required
Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report)
English Language proficiency
Excellent communication skills
Ability to work as a team player in a consulting environment
Able to manage direct relation with stakeholders and project team members
Proactive approach
Results driven oriented
Full availability to travel domestically and internationally: up to 75%
Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus
Proficiency with MS Office tools
Documentation management
GMP Consultant
Summary:
Responsible for conducting GMP/GDP audits to suppliers/contractors, within designated Quality Auditing areas.
Essential duties and responsibilities include, but are not limited to, the following:
Prepares and conducts GMP/GDP auditsto suppliers/contractors as guided by PQE TPA team.
Conducts audits in accordancewith PQE standard operating procedures and client’s directives.
Evaluates and ensures that Quality Management System, Personnel, Premises, Equipment & Systems, Processes, and Documentation of suppliers/contractors are in compliance with GMP requirements.
Escalates immediately to PQE and Client’s Management any critical compliance issues.
Communicates audit results immediately to PQE and Client’s Management.
Timely documents the audit through a comprehensive audit report.
If required, managespost-audit activities by reviewing and following up on the auditee CAPA plan.
Coaches and supervises juniorauditors, if requested.
Education & Experience:
BS/BA with 5-7+ years ofrelated experience in Biotech/Pharmaceutical industry, 2-5 years of auditexperience in GMP environment.
Skills:
Respectful of ethicalprinciples
Open-minded
Diplomatic and collaborative
Observant and Perceptive
Tenacious
Decisive
Self-reliant
Acting with fortitude
Open to improvement
Culturally sensitive
Project management
Prioritization skills
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English (at least B2/C1 level)
Others:
Availability to travel domestically and abroad. This position requires approximately 50% travel.
Excellent use of major productivity SW (e.g.: MS Office)
1. 询问详细信息，可联系Vera Zhang，固话：+86 021-80109116 。
2. 简历请发至邮箱 v.zhang@pqegroup.com 和 c.canosa@pqegroup.com，请提交中文或中英简历。
3. 长期关注职位需求，欢迎扫描文末二维码关注PQEGroup微信公众号，前往前程无忧、智联招聘主页。
PQE部分员工合影
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关于PQE Group
PQE Group，始于1998年，ISO 9001认证的完整质量解决方案供应商，从美国到日本，23处办公室遍布全球。我们积聚了数百位行业专家，以25种语言、全球化的思维、先进的实践经验，为您提供数据可靠性保障、数字化管理、确认和工程、GxP合规、药政事务、和第三方审计等方面的服务。
