QC Professional Analyst - Validation - Sanofi

• Job purpose:

  to perform the all analysis cycle for Boehringer Ingelheim products that will be transferred to Sanofi Cairo site starting from performing applicability to the test method them performing Method validation/Transfer then participation in the process validation and any assigned tasks related to the Project .

  1- Performs all physio-chemical 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 & verification runs.

  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.

  Education: Bachelor Degree in Pharmacy

  Related Experience:  1-3  years experience in related positions, preferably in pharmaceutical company.

  Special Knowledge/Skills:

  • command of English Language
  • Good computer skills
  • Familiar with new instrumental analysis techniques

  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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