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Title:  Sr. Specialist - Quality Compliance

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.


Summary of the Responsibilities/Job summary:

 

  • Provide input to management so that they can make informed decisions
  • Keep management informed of actual or potential risks
  • Identify areas of opportunity for improvement
  • Assess personnel training effectiveness
  • Ensure ongoing compliance and conformity to regulations and standards
  • Determine system and process effectiveness and highlight the efficiencies.
  • Owning the Auditing system in Julphar for the internal Audits and External Audits

 

Detail of the Job Responsibilities/Key result areas:

 

  • Responsible for developing the internal audit schedule and its execution for all facilities of julphar.
  • Carry on the Lead Auditor responsibilities.
    • Communication with the client, for the Audit Preparation
    • Provides audit team selection input if requested to do so.
    • Communicates audit plan and requirements to auditee.
    • Plans the audit and directs the audit team.
    • Conducts audit process meetings.
    • Performs the audit to collect evidence to verify conformance or nonconformance to the audit criteria.
    • Verifies the correction of previous nonconformities if directed to do so
    • Prepares audit report.
    • Manages the audit process and resolves conflicts of interest or other personnel issues.
    • Ensures reports and records are properly filed and safeguarded
  • Reports conflicts of interest to the QA compliance Manager 
  • Responsible for follow-up audit responses and writing of audit requirements to be met by individual departments through the checklist. 
  • Follow up to get a timely receipt of responses from all applicable vendors and CMOs. 
  • Training for the Co Auditors and coaching
  • Responsible for scheduling and execution of the external audits of Vendors, Contract Organizations, investigator sites, and other external organizations employed.
  • Maintain the audit reports and distribution/circulation to the vendors and track the vendor’s CAPA responses for closure on due dates with supportive evidence
  • Monthly evaluation of internal and external audit reports closed-out and pending actions for KPI and Quality Council Information.                 
  • To Perform any other responsibility assigned by QA Compliance Manager.
  • Support the Quality Management System improvement using the Quality Tools.
  • Manage the audits on the EQMS systems (Trackwise/Veeva/AmpelLogic)

 

 Core Competency:

 

  • Professional knowledge in Quality Management systems
  • Technical Background related to the GMP areas (Sterile/Non Steile /Bio-Tech) and Laboratory testing
  • Completed the Auditor Qualifcation program
  • Risk Based Approach 
  • Self confidence and indpendnacy 
  • Good Communication skills and presentation skills
  • Ethical and adheres to an organization code of conduct and complies with the
  • principles of auditing as listed in ISO 19011, section 4
  • Knowlgable about the Quality improvement tools 
  • Strong understanding and practice of 'cost consciousness'
  • Good on Process compliance  & implementation skill

 

Qualification/Functional knowledge 

 

  • Batchelor or master’s degree in science/ Pharmacy  
  • Experience of minimum of 3-7 years in the pharmaceutical industry preferably in Quality Management systems, and proven experience in Audit
  • Extensive Knowledge in cGMP and regulatory guidelines
  • MS Office proficeient
  • Statistical analysis is performed

 

We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar

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