Specialist - QA Vendor Management

Julphar View all jobs

  • Ras al-Khaimah
  • Permanent
  • Full-time
  • 10 days ago
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.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.Job Summary/Main Purpose:To adhere with the cGMP principles and to maintain them in an effective manner. Responsible for Quality Assurance functions of Vendor Management.Key Responsibilities & Key Result Areas
  • Act as second line and program co-owner for new vendors' introduction, qualification, and assessment.
  • Act as point of contact for vendors' notifications for quality related issues and changes.
  • Oversee the quality oversight program for vendors; in addition to material complaints handling and its 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 manners reporting of potential violation or non-compliance issues to the reporting manager.
  • Investigate material complaints related to raw and packaging materials
  • 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. Review Approve and Maintain responses.
  • 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.
  • Service providers qualification management.
  • Maintain proper system related KPIs' and trending in a way that allow continuous improvement culture.
  • Handling of deviations and investigations.
Core Competency
  • 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.
Qualifications:Key Experiences / Functional Knowledge Requirements:
  • Education: Bachelor's degree in science/pharmacy / health care related.
  • Experience of overall 6+ years in Quality assurance with 3-5 years in vendor management and QMS is required
  • SAP basic knowledge.
  • Proven experience in vendor management to resolve quality issues is an advantage.
  • Good computer knowledge and knowledge of QMS systems.
  • Quality and Business decision taker.
  • Good knowledge and command in cGMP.
  • Prior experience in handling similar roles will ensure better fitment.
  • Excellent command in English (communicating, writing and speaking) Good Knowledge and command on cGMP and audit readiness.
  • Effective oral & communication skills.
  • Reliability, teamwork and influencing skills.
  • Computer knowledge and proficient in English.
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