现场质量保证专员
康泰伦特(上海)商贸有限公司
- 公司规模:50-150人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-12-25
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:2年经验
- 学历要求:本科
- 语言要求:英语良好
- 职位类别:药品生产/质量管理 质检员/测试员(QC)
职位描述
SUMMARY OF ESSENTIAL FUNCTIONS:
Candidate must be flexible and have well-developed organizational skills and have the ability to interact with all levels of personnel. Candidate must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. Candidate is responsible for assisting in managing the development, implementation and maintenance of quality assurance standards and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards.
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
· The inspection, sampling and retention of materials and products received;
· Check the identity and quantity of each material issued to production against the Bill Of Materials (BOM);
· Perform routine conduct and reporting of in process checks to ensure operation compliance including line clearance check, daily in process report and reconciliation;
· Check the quality, accuracy and consistency of the labels printed in the print room;
· Report failures or concerns to Production Supervision and Quality Management Team;
· Review of relevant batch documentation of the finished product;
· Work closely with peers on timely completion of deviation investigation and follow further checks, remedial action and required documentation;
· Collect environmental, water, and air samples as required. Communicate with contract laboratory performing analysis. Evaluate and report data;
· Assist in preparing the regulatory authorities, customer audits and self-inspection;
· Develop new procedures, and review and update existing procedures;
· Use and extract information from the following systems: JDE, TrackWise and ComplianceWire;
· Support activities of Quality Manager;
· Supports Quality Management Review;
· Supports Document Management as needed;
· Support validation activities as needed.
POSITION REQUIREMENTS:
Education: Bachelor Degree
Experience: 3 years or above of experience working in a pharmaceutical/device packaging industry with emphasis in the clinical space preferred. Licensed pharmacist preferred.
KNOWLEDGE/SKILLS:
· Good mathematics skills, statistical software or application skills preferred;
· Good written English is required ;
· Understanding of pharmaceutical procedures;
· Candidate must have the ability to work effectively under high pressure with multiple deadlines;
· Candidate must be detailed oriented with good oral and written communication skills and good interpersonal skills;
· Candidate must have computer skills with MS Office and capable of quickly learning other software including Documentum, TrackWise and ComplianceWire.
PHYSICAL/MENTAL REQUIREMENTS:
· Mathematical and reasoning ability;
· Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form;
· Ability to work effectively under extreme pressure to meet deadlines;
· Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
· Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment;
· Specific vision requirements include reading of written documents and use of computer monitor screen frequently;
· Overall about average intelligence, creative thinker with sound business judgment. Good negotiation and reasoning skills;
· Excellent written and verbal communications skills;
· Ability to easily learn and retain technical information;
· Must be fluent in both Chinese Mandarin and English;
· Excellent problem solving skills, including innovative and creative solutions;
· Well organized with ability to handle multiple activities simultaneously;
· Self-starter with the ability to work with people at all levels within Catalent and within customer organizations.
职能类别:药品生产/质量管理质检员/测试员(QC)
公司介绍
Catalent Pharma Solutions is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry.
Why Catalent?
1. Unrivaled experience, expertise, and track record of market success on a global scale
2. #1 industry partner in drug development and drug delivery technology with 80+ years of experience
3. Partner with 48 of top 50 pharma and 41 of top 50 biotech firms and hundreds of emerging innovators
4. Serve 1,000+ customers at nearly 30 sites and 50+ clinical supply depots, supplying 7,000+ products in 80+ markets
5. Touched 75%+ of top-selling compounds and 50%+ of FDA approvals; now partnering on 500+ new products
6. $1B invested in innovation, science, technology and capabilities; 1,100+ patents
7. 18 global R&D teams; 1,00+ scientists; accelerated development and advanced delivery technologies for better treatments
8. Global scale and highest standards in quality, cGMP and EHS; exemplary regulatory record; global accreditations; LEAN operational excellence
Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance and provide superior, reliable manufacturing and packaging results.
Catalent develops. With our broad range of expert services we drive faster, more efficient development timelines to help you take more molecules to market and create more effective products.
Catalent delivers. As the world leader in drug delivery innovations, we have a proven record of enhancing bioavailability, solubility and permeability, improving ease and route of administration, and increasing patient compliance for better treatments.
Catalent supplies. Globally positioned to serve all your manufacturing and commercial packaging needs, we provide integrated solutions to take your product from design, to clinical trial, to plant, and to pharmacy.
Catalent. More products. Better treatments. Reliably supplied.
Catalent came to China in 2012, headquartered in Shanghai and just opened two new plants which are located in Shanghai Free Trade Zone and Haining, Zhejiang, with a headquarter office in Lujiazui financial zone. Catalent has identified the Chinese market as a potential growth market for all business units of Catalent.
We are seeking the best talent for catalyzing success
For more company information please visit our website: www.catalent.com
We're Hiring! www.catalent.com/careers
Join our Talent Network! http://catalent.avature.net/talent