Youssef ZAIDANE

QA / QC & HSE Manager

**, ****** ****** - ***** - ** 20410 - Casablanca, Morocco - Tel: +212.674.248.978

Email: ada8ft@r.postjobfree.com

Skills and Background

Knowledge in the quality field : Audit Management, Corrective and Preventive Actions Management, Complaints Handling, Quality Risk Management, ISO 9001, ISO 14001, ISO 45001, ISO 13485, ISO 14971, ISO 14644, ISO 14698, ISO 50001, ISO 22000 & HACCP, Pharmaceutical & Manufacturing GMP’s, FDA standards, Quality tools as : “Ishikawa’s diagram - Pareto’s diagram - F.M.E.C.A - Control cards - Experience’s plans - Brainstorming - 8D reports - Gemba walk - Mission control - Rapid improvement event - 5 Why’s - …”

Skills & Key points: QMS implementation, Quality Procedures & Writing strength, Project Management (MS Project, Gantt-Chart, …), Experience with cGMP and ISO quality assurance systems, Strong communication both verbal and written, Public Speaking, Team work, Leadership, Strictness, Extension's respect, Perseverance, Quality of execution, Able to prepare and deliver presentations to small, medium and large size audiences.

Softwares : Sage X3 ; S.A.P ; QUALIPRO XL ; Windows / Macintosh ; Office Package.

Languages : Arabic : Maternal ; French - English - Spanish : read, written & spoken.

PROFESSIONNAL EXPERIENCE

From Feb 2019 to Present : Groupe Tecnimede – QA Manager ; Manufacturing and distribution of pharmaceutical products ; Job Location at Berrechid - Province of CASABLANCA city

Implementation and maintenance of the site's quality policy in accordance with the group's standards.

Ensure process compliance in compliance with GMP.

Ensure the qualification of suppliers of pharmaceutical components.

Manage quality deviations; investigation and action plan.

Ensure a follow-up of CAPA plans resulting from internal audits, inspections and customer audits.

Implement a training policy in accordance with GMP requirements.

Propose improvement plans in relation to the pharmaceutical quality system.

Ensure PQP.

Ensure the follow-up of quality KPIs and proposals for continuous improvement.

Supervise process validation and qualifications of equipment and installations techniques.

Interact globally with other quality management colleagues by collaborating on improvement activities and sharing best practices.

Interface with colleagues to ensure harmonization of testing activities and acceptance of the components delivered with critical partners and coordination of actions corrective measures between sites.

Ensure that external services related to product quality are purchased according to the needs of the division.

Review applicable regulations and standards and determine if there are any exclusions;

Identify process requirements for QMS and their application across all facilities and determine the sequence and interaction of these processes.

Plan how to monitor, measure and analyze these processes and implement measures required to achieve the expected results.

Determine and manage the department's budgetary needs;

Review and approval of batch files for release.

From Feb 2018 to Feb 2019 : LAMATEM (Novatis Group) – QA / QC & HSE Manager ; Manufacturing and distribution of Medical devices products ; Job Location at Berrechid - Province of CASABLANCA city

Responsible for the design, implementation and operation of the Quality Management System which complies with the requirements for 21 CFR part 820 and applicable Quality System standards ISO 13485;

Function as the resident expert and advisor on 21 CFR part 11, 803, 820 and ISO 13485 and provide guidance on compliance to current ISO standards 9001, 14971, 14644 and 14698;

Functions as the Management Representative for the quality system and is the primary contact person with visiting authorities regarding quality during inspections and audits;

Supervise the local audit team, ensuring all quality system requirements are periodically audited for compliance;

Interacts directly with customers regarding quality system design and operation, hosting customer audits, codifying specifications and handling customer complaints;

Responsible for ensuring quality of products and materials consistently meet specifications according to established quality plans;

Supervise the Microbiologist/Sterilization Specialist in program compliance and duties to ensure programs remain effective;

Supervise Quality and Validation Engineers in system design, qualification and maintenance;

Supervise the Quality Assurance Supervisor and Quality Assurance Lead Technician in product testing and final release;

Interact globally with other Quality Manager colleagues by collaborating on improvement activities and sharing best practices;

Interfaces with global colleagues to ensure harmonization of delivered components testing and acceptance activities with critical partners and coordinating corrective actions between the sites;

Ensure externally supplied services related to product quality are procured commensurate to divisional needs;

Determine the budgetary requirements for the department;

From Sept 2016 to Dec 2017 : ContiTech Maroc (Continental Group) - QA / QC & HSE Manager ; Manufacturing and distribution of conveyor belts ; Job Location at Jorf Lasfar - Province of EL JADIDA city

Working with purchasing staff to establish quality requirements from external suppliers;

Setting standards for quality as well as health and safety;

Ensure adherence to health and safety guidelines as well as legal obligations;

Making sure that manufacturing or production processes meet international and national standards;

Defining quality procedures in conjunction with operating staff;

Setting up and maintaining controls and documentation procedures;

Monitoring performance by gathering relevant data and producing statistical reports;

Using relevant quality tools and making sure managers and other staff understand how to improve the business;

Making sure the company is working as effectively as possible to keep up with competitors;

Supervise inspectors, technicians and other staff and provide guidance and feedback;

Be on the lookout for opportunities for improvement and develop new efficient procedures;

From March 2013 to August 2016 : COOPER PHARMA – Quality Assurance Engineer ; Manufacturing and distribution of Pharmaceutical Products ; Job Location at Casablanca city

Insure the Quality Assurance’s check points during all the manufacturing process and validate the interface between the Quality System and the other departments.

Analyze Quality Assurance requirement and develop quality solutions & processes for the internal audit implementation.

Coordinate and investigate the organization’s incidents cases.

Achieve lot’s files reviews and the monitoring of the preventives & correctives actions within the agreed periods.

Realize proximity quality monitoring in the related departments and to set the recommendations to get under control the product’s quality all along the chain.

Monitor procedures application effectiveness, the technics inside the manufacturing working group and the respect of the good manufacturing / hygiene / recording practices.

Train and form newly recruited in their respective departments.

PRACTICAL TRAININGS & Workshops

Workshops :

Quality Assurance Testing Training in Hannover (Germany) - Duration : 1 month “February 2017”

Training led by ContiTech Germany

Implementation of the QC Laboratory in Hannover (Germany) - Duration : 1 Week “November 2016”

Training led by ContiTech Germany

Training under the theme "Investigating and addressing deviations" - Duration 3 days “November 2015”

Training led by the Training Center for Industry and Applied Research (CEFIRA - France)

Training under the theme "Air treatment in pharmaceutical production" - Duration 3 days “June 2015”

Training led by the Training Center for Industry and Applied Research (CEFIRA - France)

Academical Trainings :

From February to May 2012 : PINGOUIN S.A ; Manufacturing and distribution of Food (Ice cream) Products – Quality engineering internship

Practical training Subject : « Process F.M.E.A & Control Cards » :

Monitoring and improving the Prerequisite Program in all the manufacture’s departments.

Aware the machine operators to respect the hygiene rules established by the manufacture and also by the quality department and train the new recruited operators to the hygiene rules.

Implementation of the Control Cards (shewhart) in view to highlight the sanitary security of the Ice cream manufacturing during all the year.

From July to August 2011 : International Morocco Dessert « AMOUD » ; Manufacturing and distribution of Food Products – Quality engineering internship

Initiation to the Prerequisite programs - Track the critical malfunctions - Internal Audit.

From February to May 2010 : National Institute of fisheries Research – Training in laboratory engineering :

Quality & Salubrity of Marines environments department: « Marine Microbiology Service ».

Sample Analysis - E.Coli’s and Salmonella’s enumeration.

UNIVERSITY EDUCATION

2018-2019 : 2nd Year Phd : ‘Industrial Engineering’ - National Engineering College of Electrical & Mechanical Sciences - (ENSEM) - Casablanca

2017-2018 : 1st Year Phd : ‘Industrial Engineering’ - National Engineering College of Electrical & Mechanical Sciences - (ENSEM) - Casablanca

2011-2012 : Master 2 : ‘Biotechnology & Quality Procedures’ - Faculty of sciences Ben M’sik - Casablanca

2010-2011 : Master 1 : ‘Biotechnology & Quality Procedures’ - Faculty of sciences Ben M’sik - Casablanca

2008-2009 : Bachelor’s degree : ‘Life sciences’ - Faculty of sciences of Ain Chok – Casablanca (Morocco

HOBBIES & PERSONNAL ACTIVITIES

Tennis : Member of the « B.M.C.E » tennis team.

Mixed Martial Arts : Since November 2004 till now (Full contact / Kick Boxing / …)

Football : Fair Play Trophy for the Moroccan Inter-University Tournament 2006/2007.

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