B.Pharma Validation Senior Specialist Job Vacancy @ Sanofi

B.Pharma Validation Senior Specialist Job Vacancy @ Sanofi

Pharma Candidates with Bachelor’s degree are encouraged to apply online at Sanofi for  Specialist vacancies that are available. Sanofi is hiring Chemistry candidates for Officer vacancies. Interested candidates may apply online. Check out all the details on the same below:

Job Title: Validation Senior Specialist

No.of posts: 01

Eligibility:

  • A minimum of Bachelor’s Degree in Life sciences or Pharmacy is required
  • A minimum of 6 plus years of experience in Pharmaceuticals is required. Working experience in an Injectable Pharmaceuticals is a plus.

RESPONSIBILITIES / REQUIREMENTS :

  • Preparation and review of the Qualification and Validation documents (Qualification of facility, utilities, production and quality control equipment and instruments).
    Preparation and review of Validation Master Plan (VMP).
  • To Review URS, FAT, SAT, DQ, IQ, OQ Protocols, Reports, Risk assessment, layouts and/drawings.
  • Knowledge on Process validation, Cleaning validation, Process simulation / Media fill, Products /Materials transport validation.
  • Periodic Performance verification of the facility, utilities, production and quality control equipment and instruments.
  • To perform GAP assessment with respect to applicable Guidelines in line with site documents and its implementation.
  • Review of the Change Controls and Deviations in respect of Validation / Qualification.
  • Imparting Training to the concerned persons on Validation Protocols, VMP.
  • To Prepare the SOP related to the Qualification and Validation.
  • To review the Calibration certificates and ensure all the Validation instruments are under calibration status.
  • Responsible to maintain inventory of Qualification & Validation consumables required for responsible equipment’s.
  • To identify, correct and promptly report unsafe conditions, behaviors or potentially hazardous situations.
  • Should have excellent investigation report writing and review skills.
  • Speaking, writing and reading skills in English.
  • Should have exposure to sterile manufacturing.
  • Should have exposure to domestic and regulatory audits.
  • To be up to date with current regulatory requirements in the pharmaceutical industry.

SKILLS:

  • Strong qualification documents review skills to identify any lacunas with respect to regulatory & internal requirements.
  • Ability to improve the quality and technical aspects of procedures.
  • Requires good Qualification/Validation knowledge with respect to QC, Manufacturing, Engineering, Warehouse Instruments, Equipment’s and systems.Ability to handle situations and demonstrated good coordination between all applicable stake folders.
  • Good communication skills.
  • Ability to explain and convince customer’s implementation of proposed actions.

Apply Online

Editor’s Note: Msc Chemistry and M. Pharma Post Vacancy at Sanofi. Msc Chemistry jobs, Chemistry jobs 2019, Msc jobs, Chemical Science jobs, Pharmaceutical Science jobs 2019, Subscribe to Rasayanika for latest chemistry and Pharma jobs.

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