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