Job Ref. ID:
Quality GMP Auditor
Quality Directorate - QA Compliance Department
UNITED ARAB EMIRATES
UAE (RAK head office)
Quality GMP Auditor
Full Time Employment (Un-limited Contract)
The Quality GMP Auditor is expected to ensure the adherence with cGMP principles and to maintain them in an effective manner. He/she will be responsible for the external quality audits, quality oversight and vendors complaint management. He/she will also cover all Vendors for RM/PM, distributors, third party, CMO and service providers. Moreover, he/she will be responsible to face external quality audits hosting and participate of internal audit program.
Key responsibilities & Accountability:
Responsible to implement the role of independent verifier and evaluate vendors quality systems according to regulatory guidelines expectations. Act as the point of contact in QA compliance department with different departments and vendors for quality issues. Act as SME for managing materials complaints and perform quality oversight visit. Support of yearly external audit schedule preparation and adheres to the schedule. Assist in planning and developing assessment strategy and logistics. Perform the audit / assessment by collecting and analyzing objective evidence regarding issues and risks. Issue audit reports for the findings and communicate to the supplier and management as needed. Review and approve corrective and preventive action (CAPA) responses to the findings and assessment for adequacy, including root cause and timeliness. Follow up to get timely receipt of responses from all applicable vendors and CMOs. Evaluate and enhance audit procedures to ensure compliance with cGMPs / Regulatory requirements and company policies. Participate in internal audit program across Julphar plants. Track the vendors CAPA responses for closure on due dates with supportive evidences.
Bachelor's Degree of Pharmaceutical Science or equivalent degree in Science.
Experience of minimum +8 years of direct regulatory / cGMP compliance required. Proven experience in audit execution, handling and vendor audits/oversight.
Methodical and diligent with outstanding planning abilities An analytical mind able to "see" the complexities of procedures and regulations. Excellent communication skills
In-depth knowledge of the industry's standards and regulations guidelines e.g. PICs, WHO, USFDA, ICHICH, ISO 9001/13485/22000Excellent knowledge of reporting procedures and record keeping. Business acumen partnered with a dedication to legality.
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