Quality Control Analyst- Validation - Sanofi

• Job Purpose:

  • 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 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- Immediate reporting of out of specification test results or batch deviation reports whenever needed to the AD lab head and 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 & verfirication runs.

  9- Responsible for HSE compliance in Q.C chemical labs as Q.C representative in HSE Excellence team

  10- Fulfill other task(s) as assigned

  11- HSE & energy Contribution:

  Ensures HSE & energy approval on any SOP that requires certain HSE precautions.

  Ensures HSE & energy approval on any change.

  Following  the laboratory safety procedures Commitment to the appropriate PPE use.

  Following the approved HSE & energy policy and requirements.

  Following the statutory legislation concerning Health, Safety, environmental & energy law. Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

  Implementing good calibration program for all instruments.

  Ensures that risk assessment to any new transferred product is adequately covered.

  Ensures the availability of MSDS for any raw, auxiliary materials or chemicals used in labs.

  Key “MUST HAVE” competencies, skills & experiences

  Education: Bachelor Degree in Pharmacy

  Related Experience:  3 -5 years experience in similar positions

  command of English Language

  Good command of MS Word, Excel & Power Point.

  Familiar with new instrumental analysis techniques

  Desirable” / compromise  experience

  TQM Diploma

  At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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