Quality Assurance

Mounira ROUIBI

Adress : Toronto, Canada

Mobile : 002**-***-**-**-**

E-mail : ******.*******@*****.***

SUMMARY

Results-driven Manager and working within the Quality Department, my priorities are oriented towards Quality and Compliance within the pharmaceutical industry. My experience has allowed me to develop a solid knowledge in Quality Assurance as well as in the management of systems related to Quality Operations within a pharmaceutical environment. Oriented towards impacting results, I am recognized for my efficiency, respect for deadlines and commitment to my team. Acting as an internal auditor aiming to share my knowledge base and skills and add value to the business is allowing me to grow and participate in others development. PROFESSIONAL EXPERIENCE

Quality Assurance Manager 2020-2022

Laboratoire Groupement Pharmaceutique Algérien Algiers, Algeria

• Ensure the application of Quality Systems: In Process Control, Batches Reprocessing, Batch Records Review, Annual Product Review, Documentation, Archiving of GMP documentation, Deviations, Changes, Customer and Supplier Complaints, CAPAs, Internal and External Audits, On-site qualifications and validations, Training, Quality Risks, Market Actions, Batches Recall and Data Integrity while respecting deadlines and pre- established schedules and plannings.

• Decision making and disposition on batches manufactured on site: release of compliant batches, investigation

(following OOSs and/or deviations) of non-compliant batches and decision-making in collaboration with the Qualified Person.

• Implement and ensure respect for the Quality Culture, Policies and Values of the company with my direct collaborators (06): Quality Assurance Supervisor (01), Product Quality Assurance Officers (02), Systems Quality Assurance Officer (01), Documentation Officer (01) and Qualification/Validation Officer (01).

• Establish the Quality indicators of the site and monitor them regularly as well as sharing them during general meetings.

• Ensure regulatory and technological monitoring in collaboration with the Regulatory Affairs Department.

• Acting as internal auditor and improve Quality Management Processes and Systems.

• Implement and participate in the implementation of Quality Projects (Lean Management) and Site Projects. Quality Assurance Associate 2016-2020

Pfizer Saidal Manufacturing Algiers, Algeria

• Production and Quality Control Batch Records Management: Preparation, review and discrepancies investigation and approval while respecting deadlines.

• Documentation Management: Establishment, updating, review and approval while respecting deadlines.

• Deviations/Changes Management: Initiation on the Quality Tracking System, approval, on time closure, CAPAs implementation and CAPAs effectiveness follow-up, Quality metrics (deviations, changes, CAPAs and commitments) extraction and tracking, Quality Risk Assessments and Quality Risk Managements establishment and verification.

• Annual Products Review: Establishement, review and on time approval.

• Training Lead: Ensure and maintain the Training System conforming to GMP, Pfizer Quality Standards and local regulatory requirements, manage the Site Training System as PGS Learning Solution local administrator, follow-up and reporting of the Site Training System metrics to the Global Management, work closely with the site's departments to investigate deviations related to Human Performance/Training and provide support for the generated CAPAs.

• Conformity/Compliance: Participation in the site's compliance with Data Integrity concepts, periodic visits/walkthroughs, internal audits, local regulatory visits and global audits.

• Back-up/Interim: Provide AQ In Process Control activities, ensure the back-up of the Quality Control Laboratory and Regulatory activities on the ERP system, ensure the Compliance Associate interim, the Quality Assurance Responsible interim and the Quality Operations Leader interim. Analyst Chimist 2014-2016

Pfizer Saidal Manufacturing Algiers, Algeria

Perfect knowledge of GMPs, GDPs and GLPs, Raw Materials analysis and perfect use of the Dissolutest, KF Titrator, Disintegrator, Friabilimeter, Durometer, Fusiometer, Conductivity Meter, Polarimeter and Potentiometer, UV/VISIBLE Spectrophotometry, IR Spectrophotometry and HPLC High Performance Liquid Chromatography as well as Standard Operating Procedures and validation protocols/reports establishment and update. Administrative Supervisor 2014

Groupe ABOURA Algiers, Algeria

Ensure the administrative management of the company's employees and the proper internal organization of work, statements and payslips, leave and transfer requests, updating administrative files as well as internal promotions, training and career development plans as well as the compliance with local authorities regulations and the company's internal regulations.

Commercial Assistant 2010-2011

LBVET Veterinary Products Algiers, Algeria

Ensure the role of interface between the customers, the structure and the delegates/commercials, participate in the drafting of commercial offers and ensure the processing of commercial and administrative follow-up of orders and customers in collaboration with sales representatives and sales management, update the customers database and follow up on operations by following up on the company's customers files and monitoring, update and reporting the company's commercial dashboard.

Intern 2009

Pfizer Saidal Manufacturing Algiers, Algeria

Realization of the university project entitled: Problems encountered during the packaging of a pharmaceutical form in collaboration with the Manufacturing, Packaging, Quality Control, Methods and Plannings, Quality Assurance and Engineering Departments.

Intern 2008

Biotic, Groupe Saidal Algiers, Algeria

Introduction to the Pharmaceutical Industry: Production Units and Quality Department. ACADEMIC CURRICULUM/DIPLOMAS AND QUALIFICATIONS

Higher Studies’ Diploma in Management and Human Resources 2012 I.F.M.A ; Institut de Finance et de Management Algiers, Algeria Engineer’s Degree in Process Pharmaceutical Engineering 2010 Université des Sciences et de la Technologie Houari Boumediene Algiers, Algeria Bachelor Degree in Nature and Life Sciences 2004

Lycée Garidi II Algiers, Algeria

SKILLS DEVELOPMENT

ISO 9001 :2015, Quality Management Systems Auditor/Lead Auditor Training CQI/IRCA Course : 17977 - PR 238 2021

SGS Academy Algiers, Algeria

Data Integrity Training 2019

Pfizer-Workshop Madrid, Espagne

ERP System Enterprise One Training 2018

Pfizer-Workshop Dubai, UAE

Interpersonnel Communication Traning 2018

Etablissement de formation et d’accompagnement CESI Algiers, Algeria Trainers Training 2017

Etablissement de formation et d’accompagnement CESI Algiers, Algeria Office Agent Certificate (MS-Windows, Word, Excel, PowerPoint, Publisher & Access) 2009 Ecole de formation Descartes Algiers, Algeria

PERSONEL INTERESTS/ACTIVITIES AND LINGUISTIC KNOWLODGE Volunteer 2012-2013

Croissant-Rouge Algérien Algiers, Algeria

Arabic: Excellent.

French: C1 & C2 Levels in TEF.

English: Level 6 in IELTS.

WES: Master’s Degree in Pharmaceutical Engineering. REFERENCES

Upon request.

Contact this candidate