Sr. Specialist Quality Compliance

Ras al-Khaimah, United Arab Emirates

https://www.mncjobsgulf.com/company/julphar

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Job Description

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.
Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
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

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

Reports conflicts of interest to the QA compliance Manager
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 any other responsibility assigned by QA Compliance Manager.
Support the Quality Management System improvement using the Quality Tools.
Manage the audits on the EQMS systems (Trackwise/Veeva/AmpelLogic)

Core Competency:

Professional knowledge in Quality Management systems
Technical Background related to the GMP areas (Sterile/Non Steile /Bio-Tech) and Laboratory testing
Completed the Auditor Qualifcation program
Risk Based Approach
Self confidence and indpendnacy
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
Knowlgable about the Quality improvement tools
Strong understanding and practice of 'cost consciousness'
Good on Process compliance & implementation skill

Qualification/Functional knowledge

Batchelor or master's degree in science/ Pharmacy
Experience of minimum of 3-7 years in the pharmaceutical industry preferably in Quality Management systems, and proven experience in Audit
Extensive Knowledge in cGMP and regulatory guidelines
MS Office proficeient
Statistical analysis is performed

We value people from different backgrounds. Could this be your story? Apply today or visit to read more about us and the journey of Julphar

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