Under minimum supervision, performing detailed and timely review of chemistry raw data and results generated during Q.C. testing of raw material, packaging, stability, validation, finished and semi-finished products, and ensure that all produced data and results are in accordance with methods, specifications, SOP’s and Good Manufacturing Practices.
Responsabilies & Duties
- Verifying all laboratory documents such as laboratory notebooks, laboratory result sheets, electronic data and calculation worksheets that are generated by chemistry section of the quality control laboratory
- Approval of LIMS batches and testing and approval of laboratory results for samples out of LIMS
- Verifying all laboratory results ensuring accuracy, integrity and traceability of supporting raw data are produced in accordance with GMP, testing method and standard operating procedure
- Assist supervisors and investigators during investigations of OOS results and consult the department supervisor / manager regarding omission, deviation, incomplete results and other irregularities
Skills. knowledge & Abilities
DEC in science & 6 to 8 years of experience in a pharmaceutical laboratory
B.Sc. in chemistry or biochemistry or equivalent experience & 3 to 5 years of experience in a pharmaceutical laboratory
Extremely well organized
Detail orientedExcellent interpersonal communication skill (computer, written & verbal), good working knowledge of GMP’s and GLP’sHands on expertise with HPLC, GC and various wet chemistry techniques;Acquaintance with HPLC software