The 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.Yêu Cầu Công Việc
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 dutiesChế độ bảo hiểm
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Công ty Cổ Phần Tập đoàn Công Nghiệp Việt đã hoạt động trên thị trường được 15 năm và ngày càng khẳng định thương hiệu của mình bằng uy tín - chất lượng - giá cả cạnh tranh. Công nghiệp Việt hoạt động đa ngành nghề trong lĩnh vực công nghiệp, từ thương mại đến sản xuất, gia công - chế tạo các máy móc, thiết bị phục vụ cho dây chuyền sản xuất và thiết kế, xây lắp nhà xưởng sản xuất. Công nghiệp Việt có văn phòng chính tại Hà Nội,văn phòng đại diện tại thành phố Hồ Chí Minh, Đà Nẵng. Trong xu thế hội nhập kinh tế toàn cầu ngày nay, Công ty cổ phần Tập đoàn Công Nghiệp Việt cũng đang cố gắng không ngừng để vươn xa ra thị trường quốc tế.
Chúng tôi cam kết tạo môi trường thuận lợi nhất và cơ hội để phát triển tư duy và năng lực của những ứng viên nhiệt huyết với công việc.