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