QA Senior Specialist
Julphar
Ras Al Khaimah, UAE
منذ 4 يوم

Job Description :

Purpose : Maintain oversight of the QC activities including testing, Out Of Specifications (OOS), Out Of Trend (OOT) , perform investigations to maintain GMP and quality standards.

Key responsibilities & Accountability :

  • Ensure effective and full implementation of GMP related requirements to Laboratory Practices
  • Comply with Julphar information security and policies
  • Comply with Data integrity, privacy declarations and procedures
  • Investigate lab associated deviations and OOS
  • Providing CAPA for relevant departments from deviation reporting to close identified gaps
  • Contribute in Technical Risk Assessments for analytical method validations
  • Maintain all system inspection ready & presenting lab deviation & OOS / OOT reports to internal & external audits
  • Escalate of any schedule predicted delays, deviation outcome issues in a timely manner for Team leader & Management decision making
  • Actively participate & value add in continuous improvement initiatives.
  • Support the CAPA implementation and monitoring its effectiveness
  • Conduct & support the for On Job training wherever needed
  • Reviewing and approving master technical documents including :
  • Raw Material Specification (RMS)
  • Raw Material Purchase Specification (RMPS)
  • Standard Test Method (STM)
  • Test Method Validation Protocols (TMRP)
  • Test Method Validation Reports (TMVR)
  • Standard Operating Procedure (SOP) QA / QC
  • Stability Protocols / Reports
  • Lead and closing up laboratories investigation for :
  • Raw Material and finished product analysis out of specifications (OOS)
  • Stability out of specifications (OOS)
  • Microbiology deviations
  • Deviations related to QC & QA Operations
  • Market Complaint
  • Any other responsibilities assigned by QA Head and QA Manager. Core Competency
  • High on communication and collaboration , having an ability to manage multiple stakeholders at a time
  • In terms of competency, you are highly result oriented with strong sense of accountability & ownership.
  • Must be able to manage tasks and priorities and easily adapt to changing situations.
  • Good command in English (Communicating, writing and speaking)
  • Good prioritizing skills and being able to make a just decision also in case of (time) pressure
  • Flexible learning abilities
  • Excellent knowledge of cGMP and strong focus on clients and quality / compliance;
  • Excellent root cause analysis capabilities, Innovative abilities, creative, strong drive to improve
  • Must be highly organized, self-motivated to learn new things and implement them in building or updating quality system for Pharmaceuticals
  • Process the ability to develop and maintain an effective working relationship with internal and external sections, function as team player and comply with company policies.
  • Qualifications : - Education

  • Master Degree in (Bio)Pharmacy or related other science - Experience :
  • A minimum of 6+ years of relevant experience in similar industry (preferably in a sterile environment)
  • Must have a background in Biotech / sterile QC testing data review / trending - Training : Key Competencies :
  • Preferable to have prior experience with Insulin production process
  • Preferable experience in Minitab
  • Have strong leadership skills. Technical Competencies :
  • Data Analytics / Experience in Statistical Process Control
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