QA Coordinator Qualification Validation
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Job Description
At 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; 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 heres how the Quality Assurance Coordinator (Release & Doc. role will make an impact:
Position summary:
- Revision & Approval of master batch records to ensure compliance with validated processes.
- Responsible for preparation and reporting of site validation activities.
- Responsible for preparation and reporting of Thermal Mapping activities.
- Liaise Site Validation activities with Supply Chain to ensure supply & avoid out of stock
Job Specific technical/Functional/Professional Competencies:
- Validation/Qualification activities:
- 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 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.
- Member of Site Validation Committee.
- Participate in internal audit program as auditor.
- Conduct Periodic Product Record Reviews.
- Responsibility for implementation of Data integrity program in the relevant work area
- Delegate for senior Validation and Qualification associate (if needed).
Experience and Knowledge
- Bachelors degree in Pharmaceutical Sciences or related field
- Minimum 1 years of relevant experience in Quality functions with knowledge in:
- InProcess Control.
- Cleaning Validation.
- Process Validation.
- Packaging Validation.
- Systems Validation.
- Periodic Product Record Reviews.
- Quality Control
- Six Sigma methodologies
Essential Personal Qualifications
- Good command of English both written and spoken.
- Knowledgeable with interpersonal learning.
- Communication teaching and coaching skills.
- Logic way of thinking
- High analytical skills
- Problem Solving Skills
Preferred Qualifications
- Six Sigma Green Belt Certified
- Internal Audit Training
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.
Required Experience:
IC
Employment Type
Full-Time
