Quality Control Assistant Manager
JULPHAR
Total des années d'expérience :19 years, 0 Mois
System company validation and documentation in FDA products (Vancomycin HCl injection and Calcitriol injection).
•Developing methods of analysis of drugs in biological fluids and materials.
•Working on special projects applied on HPLC, UV, GC and NIR.
•Demonstrate strong project leadership.
•Demonstrate excellent practical and theoretical knowledge of instrumental techniques
•Collaborate with the PDL, QA, Production, Regulatory affairs and Medical Affairs in order to gather the relevant information required for the product submission to the different Health Authorities.
•Establish and maintain effective working relationship with my colleagues and other employees.
•Certified Basic current good manufacturing practices and good laboratory practices training
•Proficiency in SAP system analysis & Data feed.
•Updating of the Raw Material Specifications (As per FDA Requirements).
•Review and investigate complaint issues from different countries regarding the drug quality.
•Edition and approval of CoA of finished products.
•Authorized from MOH for final release of raw materials and finished products.
•Leading internal audits.
•Review of the batch documents before release.
•In-Process and analytical validations of analysis methods of generics.
•Validation and Verifications of Standard Test Methods (As per FDA Requirements).
•Writing the Standard Operating Procedures for Q.C Instruments (As per FDA Requirements).
•Collaborate with the Calibration & maintenance departments for regular calibration of Q.C instruments.
•Proper investigation of OOS products according to FDA guides lines.
1- System company validation and documentation in FDA products (Vancomycin HCl injection and Calcitriol injection).
2- Developing methods of analysis of drugs in biological fluids and materials.
3- Working on special projects applied on HPLC, UV and NIR.
4- Demonstrate strong project leadership.
5- Demonstrate excellent practical and theoretical knowledge of instrumental techniques
6- Collaborate with the PDL, QA, Production, Regulatory affairs and Medical Affairs in order to gather the relevant information required for the product submission to the different Health Authorities.
7- Certified Basic current good manufacturing practices and good laboratory practices training
8- Proficiency in SAP system analysis & Data feed.
9- Updating of the Raw Material Specifications (As per FDA Requirements).
10- Review and investigate complaint issues from different countries regarding the drug quality.
11- Edition and approval of CoA of finished products.
12- Authorized from MOH for final release of raw materials and finished products.
13- Leading internal audits.
14- Review of the batch documents before release.
15- Validation and Verifications of Standard Test Methods (As per FDA Requirements).
16- Writing the Standard Operating Procedures for Q.C Instruments (As per FDA Requirements).
17- Collaborate with the Calibration & maintenance departments for regular calibration of Q.C instruments.
18- Proper investigation of OOS products according to FDA guides lines.
19- Approve alternate vendors after consulting with the QA manager.
20- Monitoring and periodic evaluation of the effectiveness of the quality policy by reviewing the technical documents like (SOP’s, specifications, protocols, Change controls, etc)
21- Conducting interviews for recruitment of new staff.
22- support registration of new and existing products by providing technical documents required by regulatory affairs department.
23- Preparation of the department budget
Responsible for the day to day running of the Pharmacy. Providing a professional sympathetic and supportive service to patients and identifying the right healthcare solution to meet their needs.
Duties:
•Accurately dispensing drugs to patients according to a doctor’s prescription.
•Checking prescriptions for errors & making sure they are appropriate for patients.
•Measuring, packaging, labeling and recording medications issued to patients.
•Instructing patients on how to use medications, possible side effects and storage.
•Contacting and working closely with other healthcare professionals.
Gulf Pharmaceutical Industry (JULPHAR).
Gulf Pharmaceutical Industry (JULPHAR).
Telephone. 00971566570211