上海招聘

我们需要在制药领域寻找验证服务经验丰富的人士，主要针对实验室以及生产阶段的仪器设备，安全防护产品，洁净室环境管理，计算机系统验证等。需要熟悉各类制药行业的法律法规。有参与公司质量体系搭建的经验，尤其是在生物制药领域的公司。能够操作各类常见的质量分析检测仪器和测试仪器。在未来，这个角色需要带领团队和建设团队能力，以便给客户提供卓越的服务。该角色的职务可根据候选人的资质设为工程师、主管或经理级。

Experienced to do validation work with major scope as equipment and instruments, PPE/Safety products, Clean-room environment, Computer system validation, etc. Be familiar with different regulations and compliance requirements in Pharmaceutical industry; Have proven records involved in setting up quality system especially in Bio-Pharma companies. Hands-on experience to operate QC analytical equipment and T&M instruments. in the future, need to lead a validation service team and build up outstanding capability to serve our customers. Job title could be varied from engineer to manager level upon candidate’s qualification.

Key Responsibilities:

1. In general, prepare both Tech and commercial proposal, and provide validation service to our customers.

2. DQ: with quality by design concept, according to customer needs, to write equipment and instrument SPECs with full consideration to regulations/process/functions. Recommend products to meet DQ descriptions.

3. IQ/OQ: when installation condition is ready, upon customer needs, to provide Installation/Operation qualification service, product training and others. Get customer’s acceptance to product and documents.

4. PQ: evaluate production environment and equipment status, define quality level/requirements with consensus, then to design ‘commissioning & qualification master plan’, and execute together with customers, to meet Process needs and Quality levels. Sign up documents with testing evidence as a must.

5. As potential team leader, need to coach and develop junior service engineers, improve overall capability of the team.

6. Design SOP and evaluation standard/process to ensure our outstanding service level.

7. Consultancy service to customer like New QC-Lab, GMP/GLP relevant requirements, Risk assessment, Validation acceptable criteria, OOS analysis, etc.

8. Provide training courses to both internal teams and external channel partners.

9. Coordinate with internal technical teams to resolve product relevant problems to meet requirements in Pharmaceutical industry.

Minimum Requirements/Qualifications:

1. More than 6-year work experience in Pharmaceutical industry with commercial sense.

2. Familiar with GxP requirements like GMP/GLP/GEP, good understanding to regulations from FDA, CFDA/NMPA, EMA, MHRA, ICH-8/9/10/14, WHO, ISPE, ASTM E2500, etc.

3. Work experience, prefer with Quality Control/Quality Assurance or Drug research work or Bio-Pharma Process Engineer background.

4. Familiar with most QC analytical equipment, Test & Measurement instruments, participated validation work for more than 3-years.

5. Capable to write documents like validation master plan, 3Q documents and detail reports.

6. Major in Pharmacy Engineering, Bioscience as a plus.

7. Good language skills in both Chinese and English

8. Good to have some people management experience with few subordinates.

Non-Negotiable Hiring Criteria:

1. Must be able to travel frequently within China on business trips and at times travel internationally.

2. Must be able to function independently, be self-motivated and yet be part of a team.

3. Must possess strong communication skills both verbal and written to communicate directly with customers and share technical information and provide documents.

4. Must possess strong organizational skills to meet deadlines and service customers in a timely manner

Working Conditions:

Normal office environment, travel required as needed (estimate as 20% minimum)

We celebrate the power of science & its capacity to create a healthier & more secure environment for people in the world.
When scientific advancement and technological innovation converge, we meet the needs of our customers everywhere. We support the expanding needs of scientists throughout the world. Accepting that challenge comes with responsibility as we know that the scientific innovations of our customers can’t wait. Working with urgency and purpose, Antylia Scientific brings mission critical products to our customers in support of their quest to discover and manufacture new therapeutics, vaccines, and diagnostics. We see the future of science through a sharply focused lens of human experience...
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