Tính chất công việc
Full-time
Vị trí/chức vụ
Nhân viên/Chuyên viên
Ngày đăng tuyển
25/06/2024
Yêu cầu bằng cấp (tối thiểu)
Đại Học
Yêu cầu kinh nghiệm
Trên 4 năm
Yêu cầu giới tính
N/A
Địa điểm làm việc
⇒ 930 C4 đường c, Khu CN cát Lái Phường Thạnh Mỹ Lợi, Q2,Hồ Chí Minh
Việc làm Hồ Chí Minh Việc làm Quận 2The individual in this position should have a strong working knowledge of the GMP QC laboratory environment and laboratory equipment associated with physical chemical analysis. The QC-RD Analytical Specialist is responsible for providing technical and laboratory support to the QC analysts in Nadyphar specifically working with the team as a trouble-shooter. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail. The individual must be able to perform routine tasks with a minimum of supervision.
Perform all lab functions in compliance with EU-GMP. • Develop and validate for analytical method of material, finished products, cleaning and regulatory dossier. • Follow written procedures and test methods, as trained and qualified. • Recognize and report aberrant test results and sample conditions. • Test research samples of drug product according to stability protocol, API and intermediates. • Perform dissolution profiles for in vitro dissolution study and writes the reports. • Ensure training is current for all job functions performed. • Provide QC SME and day to day technical guidance to QC analyst personnel. • Support the QC management team as required • Lead and provide SME support of investigations, CAPAs, deviations and change controls in a timely manner, • Training lead in specific assays overseeing the execution of all training activities for all new personnel. • Support and drive continuous improvement initiatives within the QC department. • Management of method validation projects and raw material evaluation projects • Transfer and Validation of compendial methods • Prepare the report, change control, GMP documentation.
Management of the critical reagents within the lab. • Perform equipment supplier audit, and plan for equipment procurement. • Management and generation of Certs of Analysis. • Perform technical review and authorization of data generated in laboratory. • Represent the QC department in internal and external audits • Write quality part of the dossier, answer Deficiency Letters to registration agency. • Own the close out of actions/ recommendations identified from both internal and external audits. • Scheduling of work across teams. • SME in the development, operation, and evaluation of training/re-training programs. • To carry out other activities as requested by the QC Supervisor/Management.
You will need to have: •
Pharmacist/ BSc in Chemistry, 4-7 years’ experience, or equivalent combination of education and experience.
We would prefer for you to have: •
In depth knowledge of current regulatory requirements for Chemistry or Biochemistry methods in support of EU-GMP/cGMP operations supporting clinical and commercial manufacturing. • Good technical knowledge in the area of Biochemistry or Chemistry. • Good experience in investigation methodology and method troubleshooting • Ability to follow written procedures with close attention to detail • Good report writing and technical writing skills. • Ability to function with minimal supervision for routine job duties
299/22 Lý Thường Kiệt, Phường 15, Quận 11, Hồ Chí Minh
Hiện là một trong những công ty sản xuất thuốc chữa bệnh có uy tín tại Việt Nam, với những sản phẩm đa dạng có sự tập trung cao nhất về chất lượng sản phẩm và phục vụ chính sách... [Xem thêm]
Chú ý: Nếu bạn thấy rằng tin tuyển dụng này không đúng hoặc có dấu hiệu lừa đảo, hãy gửi phản ánh đến chúng tôi
Hồ Chí Minh 01/07/2024 Đến 20 triệu VNĐ
Quận 12 04/07/2024 Từ 10 triệu VNĐ
Quận Bình Tân 07/07/2024 9 - 11 triệu VNĐ
Thủ Đức 19/07/2024 Thỏa thuận
Thủ Đức 20/07/2024 Thỏa thuận
Thủ Đức 25/07/2024 Thỏa thuận
Thủ Đức 28/07/2024 25 - 40 triệu VNĐ
Quận 7 13/07/2024 12 - 18 triệu VNĐ
Quận Tân Bình 24/07/2024 10 - 12 triệu VNĐ
Hồ Chí Minh 01/08/2024 10 - 15 triệu VNĐ