Senior Specialist Solid Dose Validation (Pharmacist)
Julphar
Ras Al Khaimah, UAE
منذ 3 يوم
source : Drjobs.ae

Job Title : Senior Specialist Solid DoseValidation (Pharmacist) Division : QA Operations Country : UNITEDARAB EMIRATES Work Location : UAE (RAK head office) Job Type : SeniorSpecialist Solid Dose Validation (Pharmacist) Employment Type : FullTime Employment (Un-limited Contract) JobDescription : Purpose : Maintain oversight of the process of Solid dose product(s) assignedEnd to End (from raw material to packaging) throughout thecommercial life cycle starting tech transfer to productdiscontinuation.

Key responsibilities &Accountability : Key Responsibilities & Key Result Areas

  • Ensure effective and full implementation of GMP relatedrequirements to Solid dose products validation practices
  • Comply with Julphar information security and policies
  • Comply with Data integrity, privacy declarations andprocedures
  • Create / Update protocols as perrelevant Non sterile VMP
  • Execute VMP activities relatedto Solid equipment Qualification, Cleaning & ProcessValidations
  • Providing CAPA for relevantdepartments from validation reporting to close identified gaps
  • Participate as SME in all deviations relevant to Solidbatches and contribute in identification of root cause andidentification of CAPA
  • Contribute in Technical RiskAssessments for process improvements
  • Maintain all systeminspection ready & presenting Validation reports tointernal & external audits
  • Escalate ofany schedule predicted delays, validation outcome issues in atimely manner for Team leader & Managementdecision making
  • Actively participate & value addin continuous improvement initiatives.
  • Supportthe CAPA implementation and monitoring its effectiveness
  • Conduct & support for On Job training whereverneeded Qualifications : - Education
  • Master Degree in(Bio)Pharmacy or related other science (e.g. process technology,Chemistry) - Experience :
  • A minimum of 6 yearsof relevant experience in biopharmaceutical and / or Solid doseindustry (preferably in a sterile environment)
  • Must have background in Biotech QC testing data review / trending
  • Must have background in Solid QC testing datareview / trending
  • Must have hands on experience in themanufacturing of tablets, hard gel capsules, Oral suspension,
  • Minimum 2+ years’ Experience in FBDtechnologies
  • Minimum 2+ years’ Experience inCompaction technologies
  • Preferable experience in Minitab- 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;
  • Data Analytics / Experiencein Statistical Process Control
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