Process Lead - Audit Management & Inspection Readiness

at  Julphar

• 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:

• 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
• Facilitate and lead the site inspection readiness forum, for all the external audits and internal commitments
• Prepare the auditing system reviews and key hot topics to be escalated to the management
• 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 a full system review and revisit the Auditing plan on an annual basis.
• Support the Quality Management System improvement using the Quality Tools.
• Manage the AMS on the EQMS system (AmpelLogic)
• Ensures the confidentiality of the audit program and maintains the 2nd party’s data
• 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

• 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
• Facilitate and lead the site inspection readiness forum, for all the external audits and internal commitments
• Prepare the auditing system reviews and key hot topics to be escalated to the management
• 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 a full system review and revisit the Auditing plan on an annual basis.
• Support the Quality Management System improvement using the Quality Tools.
• Manage the AMS on the EQMS system (AmpelLogic)
• Ensures the confidentiality of the audit program and maintains the 2nd party’s data
• Promotes ethical behavior on the part of auditors and those involved in managing the audit progra