Process Lead Audit Management & Inspection Readiness

Ras al-Khaimah, United Arab Emirates

Job Description

  • 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

Julphar

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Job Detail

  • Job Id
    JD1759257
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Ras al-Khaimah, United Arab Emirates
  • Education
    Not mentioned