Work as Validation Senior Specialist at Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Post : Validation Senior Specialist
Job Description :
• 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.
• 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.
• 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.
Experience : 5+
Qualification : B.Sc, B.Pharm
Location : Toopran Mandal
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Validation
End Date : 5th August, 2019
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