Specialist Sterile & Biotech Validation(Pharmacist)‎
Ras Al Khaimah, UAE
منذ 4 يوم
source : Drjobs.ae

Job Title : Specialist Sterile &Biotech Validation (Pharmacist) Division : QA OperationsCountry : UNITED ARAB EMIRATES Work Location : UAE (RAK head office)Job Type : Specialist Sterile & Biotech Validation(Pharmacist) Employment Type : Full Time Employment (Un-limitedContract) JobDescription : Purpose : Maintain oversight of the Manufacturing of Biotechnology / SterileProcesses throughout the commercial life cycle from theproduct development / tech transfer till discontinuation Keyresponsibilities & Accountability :

  • Ensureeffective and full implementation of GMP related requirements toBiotechnology products validation practices
  • Comply with Julphar information security and policies
  • Comply with Data integrity, privacy declarations and procedures
  • Create / Update protocols as per relevantSterile / Biotech VMP
  • Execute VMP activities related toBiotech equipment Qualification, Cleaning & ProcessValidations
  • Providing CAPA for relevantdepartments from validation reporting to close identified gaps
  • Participate as SME in all deviations relevant to Biotechbatches and contribute to identification of root cause andidentification of CAPA
  • Contribute to Technical RiskAssessments for process improvements
  • Maintain all systeminspection ready & presenting Validation reports tointernal & external audits
  • Activelyparticipate in continuous improvement initiatives.
  • Support the CAPA implementation and monitoring itseffectiveness
  • Support the for On Jobtraining wherever needed Qualifications : - Education
  • Bachelors ( 4 years) / Masters in Bachelor / Master Degree inBiomedical / Electrical / Mechatronics Engineering - Experience :
  • A minimum of 3-5 years of relevantexperience in similar pharmaceutical facility (preferably in asterile environment)
  • Must have solidbackground in Sterile processing and aseptic behaviors
  • Preferable experience in Minitab
  • DataAnalytics / Experience in Statistical Process Control -Training : Key Competencies :
  • High on communication andcollaboration , having an ability to manage multiple stakeholdersat a time
  • In terms of competency, you arehighly result oriented with strong sense of accountability& ownership.
  • Must be able tomanage tasks and priorities and easily adapt to changingsituations.
  • Good command in English(Communicating, writing and speaking)
  • Goodprioritizing skills and being able to make a just decision also incase of (time) pressure
  • Flexible learning abilities
  • Excellent root cause analysis capabilities, Innovativeabilities, creative, strong drive to improve
  • Must behighly organized, self-motivated to learn new things and implementthem in building or updating quality system forPharmaceuticals Technical Competencies :
  • Excellent knowledge of cGMP and strong focus on clients andquality / compliance;
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