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Mounira Rouibi

Quality Assurance Professional

Email: adtmju@r.postjobfree.com

Phone: +1-437-***-****

www.linkedin.com/in/mounira-rouibi

Toronto, Canada

Summary

Results-driven and highly proficient professional with years of expertise driving growth and success within the quality assurance division of pharmaceutical businesses. Proven experience working with quality systems including audits. Possess exceptional managerial skills oriented towards impactful results, high efficiency, respect for deadlines, and unwavering commitment to fellow team personnel. Committed to raising overall quality standards and the organization's business value with my CQI/IRCA auditor/lead auditor certification with acute knowledge and skills required to audit a QMS against ISO 9001:2015 in line with ISO 19011. Skills & Abilities

Suppliers Qualification System

Deviation System Management

Change Control System

Computer Systems Validation

Internal & External Audits

Analytical Method & Process

Validation

Compliance Management

Product Release Strategy

Data Integrity

Professional Experience

Laboratoire Groupement Pharmaceutique Algérien, Algiers, Algeria Sept 2020 – Jun 2022 Quality Assurance Manager

Efficiently managed all quality systems including 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 adhering to deadlines and pre- established plans. Established batch release strategy for both compliant and non-compliant batches, and completed implementation of company's quality culture, policies, and values with direct collaborators (06). Defined site's quality indicators, regularly and systematically monitored indicators, and delivered prompt reports at general meetings, completed Quality Projects (Lean Management) and actively participated in site’s project monitoring.

● Improved Quality Management Processes and Systems while acting as an internal auditor.

● Played vital role in release of non-compliant batches following OOSs and/or deviations in collaboration with the Qualified Person.

● Directed prompt implementation of batch recall in line with data integrity modules; applied GxP requirements to batch recall process.

Pfizer, Algiers, Algeria Aug 2016 – Aug 2020

Quality Assurance Associate

Oversaw Production and Quality Control batch records management including timely preparation, review, investigation of any discrepancies, and approval processes. Performed documentation management from establishment, updating, and review to approval. Governed deviations/change control management process including start of Quality Tracking System, approvals, on-time closures, CAPAs implementation and CAPAs effectiveness follow-up, Quality metrics deviations, changes, CAPAs and commitments extraction, and tracking. Ensured timely establishment of annual products review and approval. Page 2 2

● Led the training and management of site training system as local administrator of the PGS learning solution while maintaining adherence to cGMP, Pfizer Quality Standards and local regulatory requirements.

● Spearheaded establishment and verification of Quality Risk Assessments and Quality Risk Managements.

● Expertly offered AQ In Process Control activities and ensured back-up of Quality Control Laboratory and Regulatory activities on the ERP system; fulfilled duties associated with the Compliance Associate interim, Quality Assurance Responsible interim and the Quality Operations Leader interim positions. Pfizer, Algiers, Algeria Nov 2014 – Aug 2016

Analyst Chemist

Conducted raw materials analysis and perfected use of instrument-based assays such as Dissolutest, KF Titrator, Disintegrator, Friabilimeter, Durometer, Fusiometer, Conductivity Meter, Polarimeter, and Potentiometer, UV/VISIBLE Spectrophotometry, IR Spectrophotometry, and HPLC High-Performance Liquid Chromatography and Standard Operating procedures.

● Designed validation protocols and produced corresponding reports in conjunction with amendments per requirement.

● Gained and applied comprehensive understanding of GMPs, GDPs, and GLPs. Additional Experience: Administrative Supervisor, Groupe ABOURA, Algiers, Algeria. Intern, Pfizer, Algiers, Algeria.

Intern, Biotic, Groupe Saidal, Algiers, Algeria.

Education

Bachelor’s and Master’s Degree in Pharmaceutical Engineering Science & Technology University Houari Boumediene, 2010, Algiers, Algeria. Diploma in Management and Human Resources

Finance & Management Institute, 2012, Algiers, Algeria. Professional Training

ISO 9001:2015 - Quality Management Systems Auditor/Lead Auditor Training CQI/IRCA Course: 17977 - PR 238, SGS Academy, Algeria.

Data Integrity Training, Pfizer Spain-Workshop.

ERP System Enterprise One Training, Pfizer UAE-Workshop. Interpersonal Communication Training, CESI Institute, Algeria. Trainers Training, CESI Institute, Algeria.

Office Agent Certification, Descartes Training School, Algeria. Personnel Skills

Excellent Communication Skills, Enthusiastic and Motivated, Sense of Responsibility and Critical Thinking, Fast Learner, and Persevering Person.

Language Proficiency

Arabic- Native.

French- Native.

English- Proficient.

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