Quality Compliance Coordinator

Viatris Egypt S.A.E Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making.   Every day, we rise to the challenge to make a difference and here’s how the “Quality Compliance Coordinator” role will make an impact: Key responsibilities for this role include: Position summary: Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Global Standards. Ensure that appropriate systems are in place to meet or exceed the requirements of the company, and regulatory authorities for the quality of the products manufactured on site. Responsible for Ensuring DI at the site, Change Management and Site Self-inspection Program.

Quality Oversight of Local External Suppliers sourcing materials to Viatris- Cairo Site. Conduct a pre-audit and periodic Quality visits to assess the supplier’s site level of Compliance to GMP Quality and Data Integrity requirements. Review pre-audit questionnaires completed by the supplier. Conduct awareness training sessions for Suppliers on various GMP related topics such as Data Integrity, Good Documentation Practice and Change Control Support in drafting Quality Agreements and submission for review and approval Support in tracking and approval of Supplier Qualification reports Follow-up Data Integrity Plan and deployment of the plan per committed timelines and report any delays to Quality Compliance Section Head Should perform Site Self-Appraisal audits as Lead Auditor Should participate in the investigation and corrective action for reported improper practice. Evaluate applicable corrective and preventive action (CAPA) responses to the assessment findings for adequacy and timelines. Responsibility for implementation of Data integrity program in the relevant work area and ensure following up ALCOA principles all over operations. Share in the preparation for quality-related audits conducted by Corporate and regulatory agencies. Responsible for tracking and reviewing assigned global Viatris Policies Gap Assessments. Responsible for insurance of compliance with GMP and Viatris Global Quality Standards Active implementation of Notification to Management procedures. Approval of child actions and ensure that child actions are correctly created. Perform Quality Impact Assessment for Site changes and support site project managers to process their changes. Monthly tracking and review of Internal Audit, BOH Actions, QAS Actions and Change Management metric Ensure compliance of Change Management System with global standards Conduct and review impact assessments for all changes. Approval of child actions and ensure that child actions are correctly created. Approval of child actions interims Delegate for Senior Quality Associate (Compliance) in his absence (if needed). The minimum qualifications for this role are: Bachelor’s degree in science / pharmaceutical sciences. Minimum 3 years of experience in quality assurance or compliance department. Essential Personal Qualifications: Good command of English both written and spoken. Knowledgeable with interpersonal learning. Good Communication skills. High Precision and Accuracy. Decision making skills. High analytical skills.

Six Sigma (yellow/ Green belt) is a plus. Knowledgeable of GMP & regulatory quality Standards A t Viatris, we offer   competitive   salar ies , benefits   and   an inclusive environment where you can use