Investigations Section Head

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 (Investigations Section Head) role will make an impact:

Position summary:

• Ensure that GMP standards as they apply to 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.

• Responsible for deviations handling system.

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.

• Responsible for managing the Investigations Handling System-Manufacturing and Complaints.

• Report site data to the Head of Global Quality on a regular basis.

• Report investigation data to the Head of Global Quality Investigations on a regular basis.

• Serve as the Site HEP Lead responsible for the Human Performance Error program.

• Review and oversee the use of the HEP Utilization Tool.

• Review and approve regulatory notification decision with significant deviations.

• Review and Approval of all Investigations-Manufacturing and Complaints.

• Establish a system for Investigations-Manufacturing and Complaints classification.

• Investigations-Manufacturing and Complaints tracking and trending.

• Ensure CAPA effectiveness.

• Approval of any interim status report.

• Review of monthly quality metrics to follow-up the performance of Investigations-Manufacturing and

• Complaints handling system.

• SQOL notification of all significant deviations.

• Responsible for approving and follow-up of the Corrective Actions/Preventive Actions generated from Investigations-Manufacturing and Complaints.

• Supporting & coaching subordinates in Six Sigma Method 1 & light lean projects.

• Aid subordinates to specify their annual objectives & follow-up the objectives progression & conduct their annual appraisals.

• Review & approve the sites standard operating procedures.

• Responsible for preparing the Critical Quality Notification Summary Reports for issues/deviations that require GQI attention.

• Share in the preparation for and escorting of quality-related audits conducted by Corporate and regulatory agencies.

• Share in the preparation of the issues that require Quality Council attention.

• Acts as QA Manger deputy in approval of the laboratory investigation reports.

• Backup in the review of C of A (Test Notes) before submission to MOH.

• Interface with regulatory agencies to discuss lot records manufacturing procedures test results and labeling.

• Member of the Internal Audit Team.

• Development of various risk assessments.

• Responsibility for implementation of Data integrity program in the relevant work area and ensure following up ALCOA and ALCOA principles all over operations.

• Active implementation of Notification to Management procedures.

• Responsibility for compliance with Viatris Quality Standards.

• Delegate for Quality Assurance manager in case of his absence (if needed).

• Delegate Quality Assurance Investigations Senior Associate in case of absence.

Experience and Knowledge:

• A bachelors degree in the scientific field or equivalent pharmaceutical experience.

• A minimum of 8 years of experience in investigations CAPA or manufacturing quality assurance experience with a strong technical background in a cGMP and Quality environment.

• Previous experience in QC or laboratory Investigations.

• Have a fundamental understanding of the investigation process as it applies to manufacturing issues.

• Have detailed understanding of the processes and systems involved in the manufacture of Solid Dosage Forms and Semi-Solids pharmaceutical. Be able to use that knowledge to investigate process deviations and atypical results and identify root causes.

• Experience with word-processing spreadsheet and presentation software (e.g. MS Word Excel Access).

• Experience using data analysis computer tools and statistical analysis is preferred.

• Experience in WHO requirements.

• Experience with relevant TW modules.

• QRM Practitioner.

• HEP Practitioner.

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.

Preferred Qualifications:

• Six Sigma (Yellow & Green Belt).

• Expert in all type of Events (Incidents/Investigations LIRs Complaints and EHS).

• Experience with relevant TrackWise modules.

• Project Manager team leader/project leader and coach.

• Experience in QA/QC/Quality Compliance.

• QRM practitioner.

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.