Process Lead

2 months ago


Ras alKhaimah, United Arab Emirates Julphar Full time

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


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