Process Lead

4 weeks ago

Ras alKhaimah, United Arab Emirates Julphar Full time

Job Title: Process Lead - Vendor Management Division: Quality Directorate - QA Compliance Department Country: UNITED ARAB EMIRATES Work Location: UAE (RAK head office) Job Type: Process Lead - Vendor Management Employment Type: Full Time Employment (Limited Contract) Purpose: The vendor management Team Leader is expected to ensure the adherence with cGMP principles and to maintain them in an effective manner. He / She will also be responsible for any vendor qualification, approval, notifications assessment, oversight, audits and materials complaint. Vendors will cover RM/PM suppliers, CMO and service providers. Key responsibilities & Accountability: Key Responsibilities: - 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. - Ensure timely manner reporting of potential violation or non-compliance issues to JMT. - Prepare yearly external audit schedule for Juphar potential vendor and adheres to the schedule. - Assist in planning and developing assessment strategy and logistics. - Lead Vendor audits and 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. - Issue 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. - Maintain proper system related KPIs’ and trending in a way that allow continuous improvement ‎culture. - Attend, Participate and Deliver Quality Council. Qualifications: - Education - Education: Bachelor degree in Science / Pharmacy / Health care related. - Experience: - Experience of minimum + 10 years of vendor management and QMS is required - Proven experience in vendor management to resolve quality issues. - Training: Key Competencies: - 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. - Methodical and diligent with outstanding planning abilities. - An analytical mind, able to “see” the complexities of procedures and regulations. - Excellent communication skills. Technical Competencies:

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