Quality Control Specialist

Job description

Main responsibilities: The main purpose of this job is to perform chemical analysis for validation samples for products according to the approved method of analysis, and prepare relevant documentation as required. Perform analytical method validation/verification studies ,Protocols & final reports. Perform recovery studies & prepare cleaning validation & verification runs. Responsibilities and Tasks: 1- Performs all physicochemical testing of samples collected during the process validation and record the results in the validation report & Certificates of analysis required and ensures that all obtained results are within the specified approved limit, using valid method of analysis. 2- Performs the analytical transfer analysis according to respective protocol. 3- Perform coaching and training for junior analyst for the Analytical method validation and explain the methodology and ensure that all the junior analyst (s) understand the method validation concept and can perform full study independently . 3- Immediate reporting of out of specification test results or batch deviation reports whenever needed to the Q.C manager. 4- Perform analytical full method validation studies , Protocols & final reports. 5- Updating of SOPs & control test methods and maintaining of relevant master files. 6- Performs Standardization for Raw Materials 7- Perform Stability testing & routine analysis tasks as assigned 8- Perform recovery studies & prepare cleaning validation & verification runs. 9- Fulfill other task(s) as assigned 10- HSE & Energy Contribution: Ensures HSE approval on any SOP that requires certain HSE precautions. Ensures HSE approval on any change. Follow the laboratory safety procedures Commitment to the appropriate PPE use. Follow the approved HSE policy and requirements. Following the statutory legislation concerning Health, Safety and environmental law. Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system. Implement good calibration program for all instruments. Supplementary Tasks: ● Utilizes, calibrates, maintains the QC equipment in the Chemical Lab according to the local SOP. ● Prepares relevant SOPs and follows up the update according to requirements. ● Perform other related duties as assigned. ● Makes sure that all activities carried on are complying with safety measurements. ● Updates methods of analysis. ● Respect of Company’s Values, Code of Ethics and Social Charter. ● Responsible for applying the HSE related requirements for the company in all working procedures ● Respect Personal Data Protection Charter. - Required Years of Experience: 3 to 6 years Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!