Job Ref. ID:
Senior Manager of External Quality
Quality Directorate - QA Compliance Department
UNITED ARAB EMIRATES
UAE (RAK head office)
Senior Manager of External Quality
Full Time Employment (Un-limited Contract)
The Senior Manager of QA Compliance is expected to ensure the adherence with cGMP principles and to maintain them in an effective manner. He/She will be responsible for the compliance of all external Quality operations related to systems and procedures for all Julphar Plants. He/She will also be responsible for any vendor Qualification, approval, notifications assessment, oversight, audits and materials complaint. Vendors will cover RM/PM suppliers, distributors, third party, CMO and service providers. Moreover, he/she will be responsible to face external quality audits hosting and audit management.
Key responsibilities & Accountability:
Responsible to implement the role of independent verifier and evaluate compliance issues according to regulatory guidelines expectations. If required, works in coordination with other departments to ensure the achievement of the objectives. Act as the point of contact for QA Compliance department with different departments during introduction of any GMP related change. Act as SME and program owner for new vendors introduction, qualification and assessment. Act as point of contact for vendors notifications for quality related issues and changes. Manage the quality oversight program for vendors and distributors; in addition to material complaints handling and close out with vendor. Act as the site point of contact for service providers evaluation, assessment and qualification. Ensure that new product launches and new vendors related changes are deployed correctly and in compliance with regulatory expectation. Assists Julphar Management Team to ensure that compliance issues within the organization are being appropriately evaluated, investigated and resolved. Ensure timely manner reporting of potential violation or non compliance issues to JMT.Prepare yearly external audit schedule 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. Summarize the findings and communicate to the supplier and management as needed. Evaluate corrective and preventive action (CAPA) responses to the assessment findings for adequacy, including root cause and timeliness. Ensure timely receipt of responses from all applicable vendors and CMOs. Review Approve and Maintain responses. Evaluate and enhance audit procedures to ensure compliance with cGMPs / Regulatory requirements and company policies. Own the process of audit hosting. Issues and Review contractual agreements (e.g. Quality Assurance Agreements) for vendors, third parties, service providers and CMOs. Review and approve batch record documents, investigations and change controls for CMOs. Attend, Participate and Deliver Quality Council.
Preferably Pharmacist / Masters in Science.
Experience of minimum +10 years of direct regulatory / cGMP compliance reguired. Proven experience in Quality Compliance and vendor management to resolve quality issues.
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 Excellent knowledge of reporting procedures and record keeping. Business acumen partnered with a dedication to legality.
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