Babiker Yousif Email & Phone Number

Sudan

Sudan

Sudan - Khartoum Bahri

Resume Summary• Technical Support and Trouble Shooting for the various devices in quality control department (Support installing, calibration and controlling of new equipment and maintaining lab equipment)• Good knowledge & experience in all pharmacopeia and Non-pharmacopeia Analytical methods for RM, FP and intermediates (assay, RS, degradation products...etc).• Good knowledge & experience in handling the following instrumental techniques (HPLC, IR spectroscopy, U.V spectroscopy, Titration…. etc).• Good knowledge in QC units working systems (sampling, testing, releasing ...etc).• Good knowledge & experience in performing analytical method validation & cleaning validation.• Good knowledge & experience in Water Treatment System Validation (for Pharmaceutical use)• Good knowledge & experience in Pharmaceutical SOPs.• Good knowledge & experience in Operational, Applications & Simple trouble shooting for Shimadzu High Performance Liquid Chromatography.

• Involvement in resolving production problems associated with semi finished product.• Assuring that products are produced and stored according to the appropriate documentation in order to obtain the required quality.• Assuring that the production records are evaluated and signed by a designated person.• Checking the maintenance of the department and equipment.• Assuring that required initial continuing training of production personnel is carried out and adapted according to need.• Monitoring and control of the manufacturing environment.• Assuring that the process validations and calibrations of control equipment are performed and recorded and the reports made available. • Assuring the proper implementation of the “cG.M.P.’’• Regulations in manufacturing, processing & packing.• Involvement in resolving analytical problems associated with raw materials, semi finished and finished products.• Assuring that Health and Safety Standards is implemented and maintained

Involvement in resolving production problems associated with semi finished product.• Assuring that products are produced and stored according to the appropriate documentation in order to obtain the required quality.• Assuring that the production records are evaluated and signed by a designated person.• Checking the maintenance of the department and equipment.• Assuring that required initial continuing training of production personnel is carried out and adapted according to need.• Monitoring and control of the manufacturing environment.• Assuring that the process validations and calibrations of control equipment are performed and recorded and the reports made available. • Assuring the proper implementation of the “cG.M.P.’’• Regulations in manufacturing, processing & packing.• Involvement in resolving analytical problems associated with raw materials, semi finished and finished products.• Assuring that Health and Safety Standards is implemented and maintained• Assuring that chemicals, solvents and glassware inventory for the laboratory use maintained.• Assuring that adequate & correct conduction of the “G.L.P.’’is maintained.• Ensuring that a quality system is implemented and maintained properly.• Establish the effectiveness of the quality system process via internal Quality Audit implementation and the assignment of auditors.• Following up the implementation of the personnel training plan, in quality awareness, motivation, GLP, cGMP, ISO and others. • Assuring that all the batch manufacturing, analysis and in-process control, are maintained in a proper way.• Reviewing & amending the standard specification & S.O.P’s according to adapted procedures.• Reviewing the master production & control records. • Generating & validating the specification of the raw/ packaging materials, intermediate/ bulk products & finished products in coordination with the relevant managers.• Ensuring proper & clear identification & proper storage of sto

Sudan - Khartoum Bahri

Master'S Degree, Pharmaceutical Analysis And Quality Control, V.Good

Activities and Societies: pharmaceutical analysis and quality controlpharmaceutical analysis and quality control

Bachelor Of Science (B.Sc.) In Mathematic & Chemistry, Chemistry

Activities and Societies: member Sudanese Chemical Society