Process Lead - Audit Management & Inspection Readiness

دوام كامل في a Laimoon Verified Company في UAE

نُشرت يوم November 14, 2024

تفاصيل الوظيفة

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

#J-18808-Ljbffr Management & Operations

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الصفحة الرئيسية الإمارات العربية المتحدة Process Lead - Audit Management & Inspection Readiness

Process Lead - Audit Management & Inspection Readiness

تفاصيل الوظيفة

Apply safely

الشركة المعلنة عن الوظيفة

Confidential

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