
Website Julphar
Job Description:
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.
Job Responsibilities:
- 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.
- 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.
- 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.
- 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.
- Maintain proper system related KPIs’ and trending in a way that allow continuous improvement culture.
- Attend, Participate and Deliver Quality Council.
- 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.
- 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.
Job Requirements:
- 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.
- Excellent communication skills.
- Methodical and diligent with outstanding planning abilities.
- An analytical mind, able to “see” the complexities of procedures and regulations.
Qualification & Experience:
- Bachelor degree in Science / Pharmacy / Health care related.
- Experience of minimum + 10 years of vendor management and QMS is required
- Proven experience in vendor management to resolve quality issues.
Job Details:
Company: Julphar
Vacancy Type: Full Time
Job Location: Ras al Khaimah, UAE
Application Deadline: N/A
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