Chuyên Viên Thẩm Định Qc

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.
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.

You will need to have: •
We would prefer for you to have: •
Pharmacist/ BSc in Chemistry, 4- 7 years’ experience, or equivalent combination of education and experience.
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

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Cập nhật gần nhất lúc: 2024-06-28 10:45:02