Industrial pharmacist with +** years’ experience on drug product manufacturing, analysis, pre-formulation

and formulation.

Looking for position as Pharmaceutical Operations Management / Projects Management / R&D and Regulatory affairs management.

Academic Year Diploma/ Institution

2020 - Master Degree in Management and strategic Business Intelligence (ongoing).

2011 - 2012 Pharmaceutical Development master program / Faculty of Pharmacy of Monastir, Tunisia. 2010 - 2011 PharmD degree / Faculty of Pharmacy of Monastir, Tunisia

2003 - 2004 Baccalaureate degree (mathematics section, Good Grade)/ Tunisia.

Work Experience

Duration

Company/Position/Responsibilities

September 2018

Berg-Life Sciences/Tunisia: Technical Operations And Business Development Director

-Equity Research, Investment opportunities Manager.

-New projects management: new parenteral manufacturing site project management (Budgeting, project coordinating).

-New drug products introduction: coordinating tech-transfer to new sites.

-Regulatory affairs and Clinical Trials studies coordinating.

-Registration and Export coordinating.

November 2017 to September 2018

Qualified Person, Senior Pharmaceutical CMC consultant:

-Senior Consultant as Project Manager: Start-up, new product launch, tech-transfer (Assistance of pharmaceutical companies on Process validation, problems solving, MAA submission)

-Personal training on technical guidelines, pharmaceutical basic operations/Process,

April 2015 to September 2017

Qatar Life Factory/Doha-Qatar: QC Manager-Authorized Person

-Approval/authorization of QC department’s SOP, Product quality profile approval, regulatory documentation review/approval.

-Laboratory auditing for Quality-Regulatory compliance, Laboratory PT scheme design and monitoring, QC staff training.

-Reviewing QA documentation, Assistance on internal audit and QA investigation.

-Production BMR review, change control review, PVP review.

-Head of technology transfer committee, leading external audit, new project implementation.

-Product release (Intermediate, Finished Product).

-Member of negotiation/consultancy team on new project.

10/2013 to

02/2015

Alliance Pharma/ Sousse-Tunisia: Technical Operations Manager

-Supervision of pharmaceutics’ development operations.

-Formulation of new drug product / Manufacturing process design/ Pilot batches manufacturing.

-Industrial Manufacturing: scale-up, validation, adoption to equipments.

12/2012 to

09/2013

Opalia-Recordatti/ Ariana-Tunisia: Senior Project Manager

-New drug product formulation (semi-solid forms, DPI), scale-up and manufacturing process problems investigation.

-Evaluation of eCTD, MAA submission process supervision.

04/2011 to

11/2012

Adwya/Tunis-Tunisia: Entry level Project Manager - eCTD elaboration (3.2.S and 3.2.P parts).

-Responsible for new project’s analytical part validation.

-New drug product formulation (solid dosage forms), assistance on manufacturing and scaling.

-Project management: Budgeting, Business development, project realization stream-map’s design and coordination, OPEX management, strategic thinking capacity.

-Private equity opportunities search and evaluation of financial experts’ counseling.

-Industrial operations management: KPI development, statistical applications.

-Soft and International relations management: Outsourcing activities development and coordination, regulatory bodies relations management, B2B opportunities exploration, CAPEX opportunities development and negotiation.

-Confirmed skills as per cGMP, WHO’s and PIC/S recommendations.

-Confirmed experience on analytical chemistry, pharmaceutical statistics and basic sciences application.

-Perfect understanding-application of pharmacopeia texts and Product quality profile review as per diversified regional and international regulations.

-Documentation review as per international regulations (FDA, EMEA, MHRA, ICH, ASQ) and technical recommendations (ISPE, SFSTP).

-Confirmed experience with quality investigational tools (CAPA, FMEA, HACCP, RCA, A3 analysis, FTA).

-Good understanding of process improvement tools (Lean management, VSM, 6-sigma, PHA).

-Confirmed experience with solid dosage forms, parenteral/Aseptic process: direct working, personal advices and supervision, process problems solving, operational quality attention.

-Aseptic Processing transfer, line/process validation-inspection (Media fill, SIP-CIP, Personal training).

-Confirmed skills on solid dosage form granulation (Wet/Dry) and coating process/formulation optimization.

-Solid, semi-solid and parenteral dosage forms formulation, pilot batches, scale-up and industrial manufacturing; Pre-formulation studies / formulation screening / Technology transfer and process validation.

-Confirmed experience with eCTD dossier review, correction and MAA process supervision (EMEA, FDA applied regulations), project management.

-Various experiences with HPLC methods modification, validation (chemical and biologic matrix).

-Understanding of diversified Quality concepts: TQM, GAMP-5, ISO 9001, 6-Sigma concepts.

-Multi-factorial industrial operations management applied to pharmaceutical manufacturing.

-Initiation with German drug regulations (AMG, AMWHV) and German pharmaceutical terminology (Ability to adapt with German speaking environment).

-In vivo bioavailability comparison (Glimepiride as API): 3 months training at Siphat laboratory, 2009.

-New drug delivery system (master program project: Fusidic Acid based nanosuspension formulation, 2012).

-Paper reading: Innovative drug delivery system for poorly water-soluble drug candidates / Biopolymers in drug delivery systems / Quality Management Guidelines.

-ERP sageX3, SPSS 18.0, MS Project, ChemBio (chemical modeling), MS office.

Arabic (native speaker)/ French (bilingual) / English (fluent)/ Deutsch (basic, short discussion).

-Sport: football, walking.

-Reading: history, Politic, business/entrepreneurial management, hand-craft applications.

-Chess, documentary movies, traveling.

-Social Activities: charity (orphans association, Tunisian Red Crescent/ International Red Cross volunteer sponsor).

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