Sr. Specialist - Quality Compliance
Julphar
Date: 2 weeks ago
City: Ras al-Khaimah
Contract type: Full time

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
Responsible for developing the internal audit schedule and its execution for all facilities of julphar. Carry on the Lead Auditor responsibilities.
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
- 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)
- 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
- 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
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