Adnen Z.

Experience

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  SAIPH

  Jun 2005 - Jun 2006

  TQP Pharma lab industry

  - Follow-up and process control of the drugs manufacturing process: preparation of liquid and solid mixtures, drying, calibration and process flow control - Sampling and coordination with laboratory for test, react depending on results- Coordination and processing of deviations with the quality assurance department- Checking the compliance with rules of sanitation, BPD and BPD during manufacture- Check and validation of the cleaning and sterilization operation of the workstations

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  Sartorius Stedim Biotech

  Jun 2006 - Jan 2009

  IPC & FPC Quality Auditor

  - In-process quality control and team work planning management- Treatment of non-conformities and animation of investigation meetings- Ensures compliance with procedures and GMP- NCR management and investigation meeting (Drafting, investigation, action plan, follow-up and closure)- Initiation and response to supplier and inter-company non-conformities- Drafting and preparation rework protocols- Committees and meetings related to deviations, improvements, and documentary updates - In-process quality KPIs- Ensure compliance by site staff with good manufacturing practices, documentaries and company working procedures- Management and objectives definition collaborators- Managing process quality team 6 collaborators: 4 coordinators and 02 quality process supervisors Show less

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  Sartorius Stedim Biotech

  Jun 2009 - Apr 2022

  - Managing 12 collaborators: 4 supervisors and 08 quality coordinators- Approval of the QMS documentation (ISO 9001 V 2015, ISO13485 V 2016)- FAT (Factory Acceptance Tests) and SAT (Site Acceptance Tests) validation when purchasing machines, QI QO QP QD VMP (validation and preparation)- Qualification, process validation, machines and management of equipment calibration- DMP ECO ECR change management, process and product modifications- Investigation and management of quality crises, complex problems (Quality tools, 8D RCA)- Risk assessment (DFMEA - PFMEA - EFMEA with PLATEAU or Excel software, WSOT, 5M)- SAP DMS and OPCENTER MES trainer and qualifying tasks - Key user SAP: approval and validation of QM SAP access rights - QM transactions Management of on stock, PMF (Workflow Product Master File) documentation and QM on SAP, RM and FP shelf lives- KPI's and operational quality performance indicators- Digitization and implementation of electronic traceability EBR “Electronic Batch Record” MES (Manufacturing Execution System)- Approval and management of process deviations from reprocessing and destruction protocols- Team member or leader for many projects (setting up MES - SAP - OUTSOURCING - MULTISOURCING - SMART CONSUMMABLE - PLASMA-SMART BR TREATMENT - ergonomic batch file)- Participation in local or multinational projects (in Germany –France-Italy- New oxford USA) Show less - Supervise 26 collaborators spread over 6 sub-departments: Quality Release, Quality System, Quality Environment Monitoring, Process quality and Supplier quality- Collection and development of Dashboard KPI's and QMS performance indicators intended for management review, in accordance with ISO9001 V 2015, ISO13485 V 2016 and GMP- Maintain and monitoring of the quality policy and the company strategy- Department’s activities daily monitoring- Monitoring and management of the ongoing projects- Weekly and daily meeting to manage activities, sharing weekly and daily performance indicators- Activities supervise, objectives follow-up and planning of different quality entities- Weekly meetings, face to face with employees and realization of EAP evaluations - Coordination with various quality activities with other local and global departments Show less - Oversee 3 collaborators: 2 customer complaints and 1 system quality- Customer complaints Management: follow-up, oversee of team activities and planning- Establishment and creation of customer complaints sub-department- Customer complaints handling: Technical expertise of defective products, investigation, CAPA, drafting and validation of investigation reports- Management of quality crises and complex complaints- Meeting and communication with customers locally and globally, with departments impacted or included in the process of handling customer complaints- Preparation and dissemination of weekly and monthly KPI's- Documentation system management DMS (Documentation Management System)- Approval, follow-up and improvement of documentary system Show less - Leading 10 collaborators: 4 quality release technicians and 6 process quality- Ensures compliance with GMP during manufacturing- Monitoring and control of compliance with specifications, procedures and stakeholder requirements- CAPA management and continuous improvement action plans- Provide technical support to carry out the investigations and the definition of action plans for non-conformities in the process during manufacture QRQC.- In-process quality follows up and quality KPIs related to deviations- Managing critical situations of release of products and raw materials in production- Active participation in process and product changes- Internal auditor - Training for new entrants- Ensure that personal site respect GMP and procedures.- Planning and monitoring targets and ensure the achievement of quality objectives.- Supplier Complaints Management Show less

  • Product Quality Manager

    Jan 2017 - Apr 2022

  • Interim Plant Quality Manager

    Feb 2016 - Jan 2017

  • Customer Complaints Manager & DMS

    Jan 2013 - Dec 2016

  • Process and Release Quality Manager

    Jun 2009 - Jan 2013
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  Septodont

  May 2022 - Jan 2024

  ANYWER GROUP : Quality Manager - QA engineer, customer : SOFIC/SEPTODONT

  Product and complaints Management (QA Engineer Consultant), customer SOFIC - SEPTODONT- Manage customer complaints and medical device materiovigilance- Prepare and present customer complaints indicators "Monthly KPI's" for the management review- Prepare and present a report on complaints "weekly meeting" with the Regional Directorthe pharmacist responsible for quality assurance- Participate in weekly meetings with management and managers of otherdepartments: weekly update on company activity- Ensure and participate in management reviews in relation to general management.- Manage internal non-conformities- Participate in the identification, definition of corrective and preventive actions (CAPA) in connectionwith the DIR and REC and other input data.- Manage changes in backup of the system quality manager- Manage all controls in place upon receipt of supplier PMs and before shipmentof goods- Comment on the quality results from the process control records with the Quality Control Manager- Manage and participate in continuous improvement projects- Documentation creation/update of documents on ENNOV Software-S Work with a team of 4 people: 1 quality control manager and process control technicians, control upon receipt of raw materials and laboratory tests.o Backup of the system quality manager and support of the regional QA director- Show less

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  Anywr

  May 2022 - Jan 2024

  Quality Manager - QA engineer

  - Quality management (Suppliers, Products, Process, Release, Environmental monitoring, Quality System , Quality Project , Customer complaints)- Validation and continuous improvement- Process and product quality management- Participation and organization of the management reviews - Environmental monitoring- Change, Deviation, CAPA, Complaints Management- QUALITY CONTROL- Risk management- Documentation management- Internal and external audits- Regulatory and Monitoring- Team Leadership and management - Project management Show less

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  Biose Industrie

  Feb 2024 - May 2024

  VALIDAPRO : Compliance and Quality Project Manager ; AQ – AQP coaching, PAI FDA preparation

  AQ – AQP coaching and improvement, PAI FDA support and preparation, customer Biose Industries• Coaching, support and sharing of recommendations for improvements: AQ – AQP, QMS, MBR, Release Process, Investigations, Deviation Management and Continuous Improvements, QRM Risk Management Strategy and facilities audit• Review of SOPs and verification of their practical implementation based on sampling and internal audit, on-site visit and remote meetings.• Review and verification of all key QMS procedures• Closing meeting with QA, AQP and quality managers• Sharing of evaluation report and mission report, structure and QMS design: strengths and improvements to prepare for the PAI Show less

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  Validapro

  Feb 2024 - now

  Quality Assurance & Compliance Project Manager

  -Compliance project management-Development project management-Quality assurance and controle management-Qualification/ Validation and Quality Assurance Project Management-Quality support missions, consulting, accompaniement, training -Validation Master Plans prepration and execution-Process, product criticality analyses and equipment risk analysis- QRM Quality Risk Management-Drafting of design, installation, operation and performance qualification and validation protocols for processes, utilities and equipment-Coordination of qualification and validation tests, in accordance with approved protocols-Analysis of the results obtained and drafting of validation reports.-Management of non-conformities - impact assessment, proposal and follow-up of corrective actions-Drafting and approval of quality and operational procedures- Audit process and continuous improvement Show less

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  Eurofins CDMO

  May 2024 - Jul 2024

  VALIDAPRO : Compliance and Quality Project Manager ; Cleaning Validation project, Eurofins IDRON

  Cleaning Validation project, customer EUROFINS (on going project)• Cleaning validation master plan• Creating and presentation of VN methodology and strategy• Risk analysis: facilitation of meetings and drafting of deliverables: AR worst case product reports, AR VN reports, sampling plan and AR and MOP matrices. VN prerequisites.• Determination of MACO residual contamination limit based on PDE, use for validation of analytical method and cleaning validation tests.• Drafting MOP cleaning equipment and training• Drafting of cleaning validation protocol and training• Drafting of cleaning validation reports on validation batches• Drafting and updating of overall site cleaning procedure• Validation and approval of documentation and deliverables Show less

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  Yposkesi, an SK pharmteco company

  Jun 2024 - Aug 2024

  VALIDAPRO : Compliance and Quality Project Manager; HT strategy implementation(Holding Time)Yposkesi

  HT strategy implementation (Holding Time), Customer : YPOSKESIE (On going project)• Documentation evaluation and assessment of HT management of equipment in relation to cleaning validation process.• Gathering and analysis of raw data available at Yposkesie• Action plan and improvements• Drafting of HT management strategy procedures:- SHT: Steril Holding Time - DHT: Dirty Holding time - CHT: Clean Holding Time• Validation and approval of procedure

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  Just - Evotec Biologics

  Oct 2024 - now

  VALIDAPRO : CSV computerized systems validation (QEV (Quality, Engineering, Validation) department)

  - Assistance, support and participation in CSV validation activities:• Computerized systems: SAP (ERP integrated management software), Dream report (Environmental control report management), PAS-X MES (Manufacturing execution system - Electronic batch record) and QBMS (Qualified Building Management System, critical parameter control of GXP zones)• IT infrastructure: DATA Centers (IT infrastructures)- Validation, review and approval of CSV deliverables, participation in executions as reviewer and approver of test cases and other CSV validation activities:• SIA system impact assessment• DIA and ERES (Data integrity and electronic record Electronic Signature) assessment• VP validation plan• URS User requirements specifications• CARA: Criticality and risk assessment• DS/FS: design and functional specifications• DQ: Design qualification• IQ: installation qualification: IQ protocol, IQ execution, IQ report• OP operational qualification: OQ protocol, OQ execution, OQ report• PQ Performance qualification: PQ protocol, PQ execution, OQ report• Deviation management and monitoring• Modifications and change management• RTM: requirement traceability matrix• Data migration planning and execution• CSI: computer system inventory list• Review and verification of SOPs and WIs related to validation activities, training and documentation management• Migration of validation docs from SharePoint to the Compliance Quest EDM system• Management of validation document signatures with DocuSign and Compliance Quest• System release note• Participation in the Technical and business Go Life• Hypercare and End to End phase participation Show less