Senior Quality Assurance Associate (Valid.)

Job Description

3803 Viatris Egypt S.A.EAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access ? Providing high quality trusted medicines regardless of geography or circumstance;Leadership ? Advancing sustainable operations and innovative solutions to improve patient health; andPartnership ? 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 QA Validation & Qualification Associate ) role will make an impact:Key Responsibilities for this role include;

• Revision & Approval of master batch records to ensure compliance with validated processes.
• Responsible for preparation, execution and reporting of site validation activities.
• Responsible for preparation, execution and reporting of Thermal Mapping activities.
• Review and approval of Equipment qualification.
• Review and approval of Utilities qualification.
• Liaise Site Validation activities with Supply Chain to ensure supply & avoid out of stock
• Ensure compliance with latest Viatris Policies for Validation and Qualification activities.
• Ensure integration of validation schedule in production schedule for implementation of validation activities.
• Conduct Continued Process Verifications (CPVs) to ensure products are in a validated state of control.
• Responsible for execution and reporting of validation/qualification activities:
  • Process Validation.
  • Packaging Validation.
  • Cleaning Validation.
  • Qualification of Controlled Temperature Units (CTUs) and Temperature Mapping.
  • Conduct process, packaging, cleaning periodic reviews.
  • Development of relevant validation master plans and SOPs.
  • Development of validation protocols and reports.
  • Conduct and participate in deviations investigations.
• Review and approval of Master Batch records, Cleaning SOPs, Qualification documents and any other GMP documents as required.
• Conduct Continued Process Verifications (CPVs) to ensure products are in a validated state of control.
• Review and approval of Equipment and Instruments qualification and Utilities qualification
• Member of Site Validation Committee.
• Participate in internal audit program as auditor.
• Responsibility for implementation of Data integrity program in the relevant work area
• Delegate for QA Validation and Qualification Section Head in case of his absence (if needed).

The minimum qualifications for this role are:

• Bachelor?s degree in Pharmaceutical Sciences.
• Minimum 3 years of relevant experience in Quality functions with background in:
• In-Process Control.
• Cleaning Validation.
• Process Validation.
• Packaging Validation.
• Systems Validation.
• Periodic Product Record Reviews.
• Quality Control
• Six Sigma methodologies
• Good command of English in both written and spoken.
• Excellent in Microsoft office (word, excel & PowerPoint)
• Knowledgeable with interpersonal learning.
• Communication, teaching and coaching skills.

At Viatris, we offercompetitivesalaries, benefitsandan 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.

Keyskills :