QIP QA Process Lead
Julphar
Ras Al Khaimah, UAE
منذ 5 يوم
source : Drjobs.ae

Job Title : QC Oversight & QIP QAProcess Lead Division : QA Operations Country : UNITED ARAB EMIRATESWork Location : UAE (RAK head office) Job Type : QC Oversight& QIP QA Process Lead Employment Type : Full Time Employment(Un-limited Contract) JobDescription : Purpose : Will adhere with the cGMP principles and lead the QA operationsactivity for the manufacturing site with ensured compliance Keyresponsibilities & Accountability :

  • PerformingQA / QC oversight activities (stability protocol review, stabilityreport review and QC related documents)
  • Performing theinvestigation of non-sterile OOSs for phase I and Phase II withMOHAP notification procedures
  • Following up theimplementation of the Quality plan according to company’squality strategy through all non-sterile sites and monitor / reportthe progress
  • Preparing the sites QA review reportingKPIs and action plan
  • Keeping and maintain a riskassessment log for all non-sterile sites Qualifications : -Education Bachelor / Master degree in Science / Pharmacy - Experience : 5 years in pharmaceutical industry in QA and / or operational rolefor pharmaceutical non sterile manufacturing.
  • Training : KeyCompetencies :
  • Good command in English (Communicating,writing and speaking)
  • Quality and Business decisionstaker
  • KPI management
  • Experience in both QC& QA is a must
  • Risk Assessment knowledge
  • Problem Solving & Strategic Agility
  • Knowledgeable with Pharmaceutical cGMP guidelines
  • Had aproved experience in quality documents issuance and review (SOP,Protocols, Assessments, etc.)
  • Had a proved experience ofmanaging QIPs as well as leading the continuous improvements
  • Ability to define the business and quality priorities
  • Had a proved experience of projects management fromquality perspective
  • Proved experience in culture changecontribution
  • SAP experience TechnicalCompetencies :
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