Julien PETIT

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Director at Reed | JSP Partners Ltd

Reed Recruitment Switzerland

Jan 2025 - Current (5 months)

• Build and maintain strong client relationships in the pharmaceutical and life sciences sectors. • Manage the full recruitment cycle: sourcing, screening, interviewing, and placing candidates in specialized roles. • Conduct market research to identify trends and workforce demands, ensuring strategic talent acquisition. • Ensure compliance with Reed’s policies and industry regulations throughout the recruitment process. • Negotiate offers, facilitate onboarding, and maintain communication with clients and candidates post-placement. • Continuously expand professional networks and refine recruitment strategies to deliver exceptional results.

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Freelance Consultant for the Pharma Industry (CQV/QA)

JSP Partners Ltd

Mar 2024 - Current (1 year 3 months)

● Developing and implementing comprehensive Commissioning, Qualification, and Validation (CQV) plans for pharmaceutical equipment, facilities, and processes to ensure compliance with regulatory standards. ● Leading risk assessments and defining critical process parameters and quality attributes for system validation, ensuring alignment with industry best practices and regulatory requirements. ● Executing validation protocols for systems and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), documenting results and findings. ● Collaborating with cross-functional teams, including operations, manufacturing, and quality assurance, to ensure validation activities align wit

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CQV Engineer

IPSIntegrated Project Services

Feb 2023 - Mar 2024 (1 year 2 months)

Write C/Q/V documents following established standards and templates, including but not limited to the following: Commissioning Forms C/Q/V Protocols and Summary Reports Standard Operating Procedures Impact Assessments Specifications (URS/FRS/DDS) FATS/SATs Perform field/site activities including, but not limited to, the following: Attend and witness FATs and SATs as a representative of IPS clients. Execution of commissioning forms and witnessing of vendor start-up and testing. Execution of C/Q/V protocols. Walkdown and verification of system drawings (P&IDs, as-builts, etc.) Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. Assist in deviation investigation and resolut

CQV Engineer

Real Staffing

Oct 2022 - Feb 2023 (5 months)

MAIN ACTIVITIES: Provide leadership of CQV activities in assigned Project(s) at the client Site (together with PM, Process Engineers, QA): acting as subject matter expert (SME) on CQV standards correct CQV project staffing, expertise and coaching to the CQV staff assigned to projects initiate necessary training on CQV-Staff / Project staff on CQV and CSV (supported by local CQV -Staff) Keeping oversight on CQV -standards, -timelines (etc.) Address immediate time/quality constraints and act adequately Force RFT thinking and approach Considering EHS Requirements Involved and support PM and Process Engineers in CQV-Planning: Development and delivery of CQV Documents: Commissioning Documents (Suppliers / Process Engineers/EMR); QV-Documents (S

CQV Document Manager

Real Staffing

Aug 2022 - Jan 2023 (6 months)

• Handle, control, verify, review and archive of CQV documents following established 21 CFR standards and templates, including but not limited to the following: • Commissioning Forms • Validation Protocols and Summary Reports • Standard Operating Procedures • Impact Assessments • Risk Assessments • Specifications (URS/FRS/DDS) • FATS/SATs • IQ/OQ/PQs • VMPs • PEPs • Work Instructions • Vendor/Contractors/Engineering Turnover Packages • Perform field/site activities including, but not limited to, the following: • Support FATs and SATs as a document controller representative of clients from a regulatory and quality perspective • Review and storage of commissioning forms and handle the list of equipment documentation from vendo

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Consultant Qualification/Validation

ABYLSEN,

Jun 2022 - Aug 2022 (3 months)

In charge of commissioning and qualification (C&Q) activities for Technical Services department to ensure that: Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment Plan and track execution of Commissioning & Qualification activities/documentation v

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Consultant - Qualification/Validation Engineer

Expleo Group

Nov 2021 - May 2022 (7 months)

- Participation in the implementation of the qualification strategy - Definition of the validation plan, the URS, the risks associated with the processes and the process parameters (CQA/CPP, QTPP) - Identification of the tests to be performed - Participation in the drafting of procedures related to qualified equipment and processes (plans, protocols, specifications, reports, risk analysis) - Control of the qualification of tools and validation of production processes according to the departments concerned - V-cycle approach, ASTM E2500, ISO, ICH, FDA 21CFR, Eu GMP, US Ph. - Data Integrity control and upgrade, data traceability according to the standards and processes in force - Control of validation results and reporting of material / proce

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Qualification Specialist

Vifor Pharma

May 2021 - Nov 2021 (7 months)

-Perform investigations into equipment failures, materials issues, procedural issues, or process problems. -Writes and executes commissioning and qualification protocols on equipment and facilities. -Supports the implementation and documentation of Corrective and Preventive Actions (CAPA) -Reviews and approve documents, procedures, policies, protocols, engineering studies, and reports. -Perform Periodic Qualification Certifications (Process Validation/ Process Verification) to ensure that the qualified state of the system in question is maintained or reinstated. -Works with Quality Assurance and suppliers to develop materials specifications, improved processes, and resolution of problems related to components, processes and equipment.

Quality Assurance Specialist

GSK

Oct 2020 - May 2021 (8 months)

-Quality Notification Management: understand problems and assess impact on product lots, participate in field investigations, review deviations - Quality complaint management: review technical investigations in the PMS/formulation sector with production - CAPA management: participate with production in the definition of CAPAs of various origins (audits, deviations, risk register, quality council), keep informed of CAPA progress - Change management: review operational documents and approve work order amendments - Quality risk management: participation in risk analysis - Quality Oversight: periodic review of GMP activities by field presence - Documentation management: review of GMP documentation and status - Review of Formu/PMS/SB62 batch rec

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Aseptic Production Technician

LFB

Sep 2018 - Apr 2020 (1 year 8 months)

Washing, preparation and packaging of material used for production - Fill & Finish sector (Goavec stainless steel material, assemblies, versilic piping, set-up filling parts) Sterilization of material (autoclaving) Cleaning and sterilization of equipment, material and set-ups (manual and CIP/SIP procedures), operation of PLCs: automatic washers, CAFR autoclaves (Apave authorization), use of PLCs under Siemens S7 Simatic Tests and controls on equipment and components (filter integrity test, leak test, WIT, diffusion ...) Preparation of caps and vials (washing, depyrogenation) Sample taking and pH measurement Use of ERP Qualiac, LIMS, Myrrhia, coswin (CMMS) Investigations following production deviations and implementation of corrective

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Production Operator

Delpharm

May 2018 - Jul 2018 (3 months)

Compression of dry medications - Sex Hormones Sector: -Production of drugs in compression station (fette P-2100 and P-3090 compressors) -Weighing (unit mass, global mass), hardness, thickness, friability, disintegration of samples for each batch (series of measurements) -Dusting and cleaning level I to III of equipment and workshops -GMP, BPD, pharmaceutical hygiene standards and work in controlled atmosphere/aseptic environment (grade D and C) -Morning shift work -Mastery of CAPM tools (SAP) - OQ/PPQ for Decommissioning of one of the Fette 3090 presses on site Translated with www.DeepL.com/Translator (free version)

Julien PETIT

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Julien's likely patterns of behavior, thought, values, and emotion. Based on the HEXACO model, OCP instrument, and Torre’s own research.