Senior Quality Assurance Associate (Investigations)

‎3803 Viatris Egypt S.A.E
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 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.
Key responsibilities for this role include:
* 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 the 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 Insure following up ALCOA/ ALCOA+ principles all over operations.
* Active implementation of Critical Quality Events Notification.
* Responsibility for compliance with Viatris Quality Standards.
The minimum qualifications for this role are:
* A Bachelor's degree in scientific field or equivalent pharmaceutical experience.
* A minimum ‎3 years of experience in CAPA, investigations, or manufacturing quality assurance experience with a strong technical background in a cGMP and Quality environment.
* Good command of English both written and spoken.
* 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 cause.
* Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access).
* Experience in PQS/WHO/PQS requirements.
* Experience with relevant TW modules.
* QRM Practitioner.
* HEP Practitioner.
* Strong interpersonal and influential skills
* Excellent in communication and project management
* Decision-making based on a risk science-based approach
* Knowledgeable with interpersonal learning.
* High analytical skills.
* Professional in reports writing.
Preferred Qualifications:
* Six Sigma (Green Belt/Black Belt).
* Expert in all type of Events (Incidents/Investigations, LIRs, Complaints and EHS).
* Experience using data analysis computer tools and statistical analysis is preferred.
* Experience with relevant TrackWise modules.
* Project Manager, team leader/project leader and coach.
* Experience in PQS/WHO/PQS requirements.
* 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.