القائمة الرئيسية

الصفحات

Senior Quality Assurance Associate (Investigations) At Viatris Egypt

 Senior Quality Assurance Associate (Investigations) At Viatris Egypt                               

Senior Quality Assurance Associate (Investigations) At Viatris Egypt

                                




                                         

 

 

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.

 

 Apply Here


تعليقات