QA Investigations Coordinator

Requirements

• Six Sigma (Yellow/Green belt).
• Expert in all type of Investigations (ER/QAR, LIRs, Complaints and EHS).
• Experience with relevant QTS modules.
• Project Manager, team leader/project leader and coach.
• Experience in PQS/WHO/PQS requirements.
• QRM practitioner.
• Trained on QAR investigator/SQA curricula.
• A t Viatris, we offer competitive salar ies , benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
• Viatris is an Equal Opportunity Employer.

Benefits

Additional Information

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 Assurance Investigations Coordinator ) role will make an impact: Position summary: Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Viatris and regulatory standards. Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site. Coordinating and Performing investigations together with responsible person. Job Specific technical/Functional/Professional Competencies: Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Viatris and regulatory standards. Preparation of monthly quality metrics to follow-up the performance of deviations handling system. Responsible for performing the "Deviations Handling system". Responsible for approving and follow-up of the Corrective Actions/Preventive Actions generated from deviations. Share in the preparation of quality-related audits conducted by Corporate and regulatory agencies. Share in the preparation of the issues that require SQRT attention. Member of the Internal Audit Team. Development of various risk assessments. Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations. Responsibility for compliance with Viatris Quality Standards. Experience and Knowledge: Bachelor's degree in pharmaceutical sciences. 0-3 years of experience in Quality in Pharmaceutical field (QA, QC, Validation) Experience in manufacturing processes is a plus. Essential Personal Qualifications Strong interpersonal and influential skills Excellent in communication and project management Decision-making based on a risk science-based approach Good command of English both written and spoken. Knowledgeable with interpersonal learning. Communication, teaching and coaching skills. Logic way of thinking. Management and decision-making skills. High analytical skills. Professional in reports writing.

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