Specialist - QA Vendor Management

<div><p>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.</p><p>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.</p><h3>Job Summary/Main Purpose</h3><p>To adhere with the cGMP principles and to maintain them in an effective manner. Responsible for Quality Assurance functions of Vendor Management.</p><h3>Key Responsibilities&Key Result Areas</h3><ul><li>Act as second line and program co-owner for new vendors’ introduction, qualification, and assessment.</li><li>Act as point of contact for vendors’ notifications for quality related issues and changes.</li><li>Oversee the quality oversight program for vendors; in addition to material complaints handling and its close out with vendor.</li><li>Act as the site point of contact for service providers’ evaluation, assessment, and qualification.</li><li>Ensure that new product launches and new vendors-related changes are deployed correctly and in compliance with regulatory expectation.</li><li>Ensure timely manners reporting of potential violation or non‑compliance issues to the reporting manager.</li><li>Investigate material complaints related to raw and packaging materials</li><li>Evaluate corrective and preventive action (CAPA) responses to the assessment findings for adequacy, including root cause and timeliness.</li><li>Ensure timely receipt of responses from all applicable vendors. Review Approve and Maintain responses.</li><li>Issue and Review contractual agreements (e.g. Quality Assurance Agreements) for vendors, third parties, service providers and CMOs</li><li>Review and approve batch record documents, investigations and change controls for CMOs.</li><li>Service providers qualification management.</li><li>Maintain proper system related KPIs’ and trending in a way that allow continuous improvement culture.</li><li>Handling of deviations and investigations.</li></ul><h3>Core Competency</h3><ul><li>In-depth knowledge of the industry’s standards and regulations guidelines.</li><li>Excellent knowledge of reporting procedures and record keeping.</li><li>Business acumen partnered with a dedication to legality.</li><li>Methodical and diligent with outstanding planning abilities.</li><li>An analytical mind, able to “see” the complexities of procedures and regulations.</li><li>Excellent communication skills.</li></ul><h3>Qualifications</h3><p>Key Experiences / Functional Knowledge Requirements:</p><ul><li>Education: Bachelor’s degree in science/pharmacy / health care related.</li><li>Experience of overall 6+ years in Quality assurance with 3-5 years in vendor management and QMS is required</li><li>SAP basic knowledge.</li><li>Proven experience in vendor management to resolve quality issues is an advantage.</li><li>Good computer knowledge and knowledge of QMS systems.</li><li>Quality and Business decision taker.</li><li>Good knowledge and command in cGMP.</li><li>Prior experience in handling similar roles will ensure better fitment.</li><li>Excellent command in English (communicating, writing and speaking) Good Knowledge and command on cGMP and audit readiness.</li><li>Effective oral&communication skills.</li><li>Reliability, teamwork and influencing skills.</li><li>Computer knowledge and proficient in English.</li></ul><p>We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar</p></div>#J-18808-Ljbffr