Process Lead - Audit Management & Inspection Readiness

Julphar
AE - Ras Al Khaimah
November 17, 2024
Management

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
Own the Auditing system in Julphar for the internal and external audits
Facilitate and maintain the audit readiness forum

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
Provide audit team selection input if requested
Communicate audit plan and requirements to the auditee
Plan the audit and direct the audit team
Conduct audit process meetings
Perform the audit to collect evidence to verify conformance or nonconformance to the audit criteria
Verify the correction of previous nonconformities if directed
Prepare audit reports
Manage the audit process and resolve conflicts of interest or other personnel issues
Ensure reports and records are properly filed and safeguarded

Facilitate and lead the site inspection readiness forum for all external audits and internal commitments
Prepare the auditing system reviews and key hot topics to be escalated to management
Responsible for follow-up audit responses and writing of audit requirements to be met by individual departments through the checklist
Follow up to ensure timely receipt of responses from all applicable vendors and CMOs
Provide 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
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)
Ensure the confidentiality of the audit program and maintain the 2nd party's data
Promote ethical behavior on the part of auditors and those involved in managing the audit program

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 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 of quality improvement tools
Strong understanding and practice of 'cost consciousness'
Good process compliance and implementation skills

Qualification/Functional Knowledge:

Bachelor's degree in Pharmacy
Minimum of 5 years experience in the pharmaceutical industry, preferably in Quality Management systems, with proven experience in audit
Qualified lead auditor from an accreditation body (IRCA/ASQ)
Extensive knowledge in cGMP and regulatory guidelines
Proficient in MS Office
Experience in statistical analysis
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Read the full job description and apply online on the recuiter's web-site

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