Process Lead - Audit Management & Inspection Readiness

1. 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
• Facilitate and maintain the audit readiness forum

B) Detail of the Job Responsibilities/Key result areas:

1. Responsible for developing the internal audit schedule and its execution for all facilities of Julphar.
2. 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
3. Facilitate and lead the site inspection readiness forum, for all the external audits and internal commitments
4. Prepare the auditing system reviews and key hot topics to be escalated to the management
5. Responsible for follow-up audit responses and writing of audit requirements to be met by individual departments through the checklist. 
6. Follow up to get a timely receipt of responses from all applicable vendors and CMOs.
7. Training for the Co Auditors and coaching
8. Responsible for scheduling and execution of the external audits of Vendors, Contract Organizations, investigator sites, and other external organizations employed.
9. 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
10. Monthly evaluation of internal and external audit reports closed-out and pending actions for KPI and Quality Council Information.                 
11. To Perform a full system review and revisit the Auditing plan on an annual basis.
12. Support the Quality Management System improvement using the Quality Tools.
13. Manage the AMS on the EQMS system (AmpelLogic)
14. Ensures the confidentiality of the audit program and maintains the 2nd party’s data
15. Promotes ethical behavior on the part of auditors and those involved in managing the audit program

C) Core Competency:

• Professional knowledge in Quality Management systems
• Technical Background related to the GMP areas (Sterile/Non-Sterile /Bio-Tech) and Laboratory testing
• Completed the Auditor Qualification program
• Risk Based Approach
• Self-confident and independent
• 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
• Knowledge about the Quality improvement tools
• Strong understanding and practice of 'cost consciousness'
• Good on Process compliance & implementation skill

D) Qualification/Functional knowledge

• Batchelor degree in Pharmacy 
• Experience of minimum of 5 years in the pharmaceutical industry preferably in Quality Management systems, and proven experience in Audit
• Qualified lead auditor from accreditation body (IRCA/ ASQ)
• Extensive Knowledge in cGMP and regulatory guidelines
• MS Office proficient
• Statistical analysis is performed