Senior Quality Control Compliance
- القاهرة
- دائم
- دوام كامل
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.Every day, we rise to the challenge to make a difference and here’s how the (Senior Quality Control Compliance) role will make an impact:Position summary:Responsible for the QC laboratory functions (Compliance) and the corresponding documentation to support the timely disposition of product.Job Specific technical/Functional/Professional Competencies:Develop and implement quality control compliance strategies.Review all company policies pertinent to Quality Control compliance in terms of, but not limited to, equipment management (e.g., IQ/OQ/PQ, preventive maintenance, data integrity assessment and implementation, software validation activities, etc.) and ensure the adherence of internal procedures to Viatris global policies and applicable regulations, standards, and guidelines.Perform computer system validation and verification activities for all QC equipment.Conduct Audit trail review for all QC equipment with respect to the stated frequencies of each machine.Prepare and execute QC annual CAPEX plan with a close follow-up for ordering receiving and qualifying newly introduced system meeting the department budget with zero tolerance unless otherwise justified.Closely Follow-up and execute QC department Qualification/Calibration program in addition to preventive maintenance and DI activities for all QC equipment while maintaining all visits vendors’ records.Ensure implementation of EHS measures/actions within QC laboratories.Trouble shooting for all QC instruments malfunctions.Implement Data integrity program in the relevant work area and insure following up ALCOA+ principles all over operations.Contribute to laboratory investigations as a QC testing SME in addition to supporting analysis as an expert analyst to identify root cause and probable CAPAs.Monitor and analyze quality control data and metrics to identify trends, deviations, and areas for improvement. Implement corrective and preventive actions as necessary.Stay updated on regulatory changes and industry best practices related to quality control, providing guidance and recommendations to ensure continuous compliance.Coordinate and support external audits and inspections from regulatory authorities and customers, ensuring timely responses and resolution of any identified non-compliance issues.Drive continuous improvement initiatives within the quality control function, promoting a culture of quality and compliance throughout the organization.Maintain documentation and records related to quality control activities, including test results, inspection reports, and corrective actions.Active implementation of Notification to Management procedures.Experience and KnowledgeGood command of English in both written and spoken.Excellent in Microsoft office (word, excel & PowerPoint)Knowledgeable with interpersonal, good communication and presentation skills.cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.Solid experience in Laboratory equipment Qualification/Calibration/Computer System Validation.Strong Knowledge of FDA 21 CFR Part 11 requirements.Essential Personal QualificationsBachelor’s degree in Pharmacy or Science.2-4 years’ experience in a related areaDemonstrated ability to work independently.Excellent documentation and technical writing skills.Able to work in a team, interact with various priorities and meet deadlines.Active, organized and planner with high attention to details.Time management, people management and decision-making skills.Ability to interact with various priorities with good communication with stakeholders.High observation skills.Hard worker & self-motivated.At Viatris, we offer competitive salaries, 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.