Senior Quality Assurance Associate (Investigations)

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 (Senior Quality Assurance -Investigations) 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/Review/Approve 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.
• Act as “Deviations Handling system” process owner through following;

• Responsible for performing quality review and impact assessment of assigned deviations as Quality point of contact.
• Support opening investigations, conduct interviews and walking the process. Ensure that each confirmed case is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done on the case to enable an investigation with appropriate quality outcomes including a well written case summary (meets defined quality standards) which can be used in a regulatory inspection.

• Responsible for follow up and approving of the Corrective Actions/Preventive Actions generated from deviations.
• Act as Quality POC for assigned investigations.
• Delegate for Deviation SH activities.
• Responsible for preparing the “Global Quality Investigations Reports” for issues/deviations that require GQI attention.
• Annual deviations trending.           
• Support in the OBW for I initiative (One Best Way for Investigations) in VIATRIS Cairo through following;

• Actively performing routine investigation system assessment and analysis of the site investigation system to discuss opportunities regularly with SIL / QA Section Head.

• Report HEP (Viatris Human performance) utilization monthly to SIL / QA Section Head.
• Follow Up over site action plan and discuss completed actions / constraints with SIL on monthly basis.
• Share in the preparation of quality-related audits conducted by Corporate and regulatory agencies.
• Work with the appropriate people from both the quality and operational organizations develop a corrective action. Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards.
• Responsibility for compliance with Viatris Quality Standards.
• Responsibility for compliance with Viatris Quality Standards
• Share in the preparation of the issues that require Quality Council attention.
• Member of the Internal Audit Team responsible for sharing as a lead auditor in the site’s internal audit campaigns.
• Development of various risk assessments.
• Responsibility for implementation of Data integrity program in the relevant work area and ensure following up ALCOA/ ALCOA+ principles all over operations.
• Active implementation of Critical Quality Events Notification.
• Responsibility for compliance with Viatris Quality Standards.

Experience and Knowledge:

• A bachelor’s degree in the scientific field or equivalent pharmaceutical experience.
• A minimum of 5 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 QC/QA/Quality Compliance.
• QRM practitioner.
• Trained on investigator/SQA curricula.

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.