Julien PETIT

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 resolution of problems and issues encountered during field execution activities. Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required. Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. Other duties as assigned

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 versus project(s) timeline Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation) Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners Coordination and oversight of external supplier

- 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 / process anomalies - Carrying out the quality protocol tests - Completion of validation documents and creation of files including the qualification/validation report - Collecting the results of material controls in the departments concerned - Proposal and implementation of quality, preventive or corrective actions - Share key information on qualification topics within the team and across departments - Qualification and Validation of various systems/equipment (Clean/Industrial Utilities, Infrastructures, Computerized/Automated Systems, Laboratory/R&D equipment, Production equipment)

-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. -Identifies the root cause of problems and develop recommendations for cost effective solutions to prevent the problem from reoccurring. -Identifies opportunities to improve the commissioning and qualification program while assuring or enhancing the state of compliance. -Ensures compliance with all Company policies and procedures including safety rules and regulations. -Operates in accordance with a Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements - Performs all work in support of the company's Values: Collaboration, Courage, Perseverance, Safety, Respect, Teamwork and Passion -All other relevant duties as assigned. -Works with regulatory tools such as Eudralex, FDA "21CFR part 210/211" , ICH Q8 Q9 Q10, ISO 14001, 9001, 17025, 10012, 13485, USP

-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 records - Participation and application to EHS activities -Project of implementation of an admixture manufacturing process on SKID SB62 (driven by Delta V system v14): update of batch record reviews (campaign/off-campaign mode), Batch Report, CheckLists for filters, Checklists for tanks, CIP, piloting of unplanned events by pluridisciplinary group, deviation management

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 actions with dedicated departments (level 1 and 2 maintenance, calibration of production equipment, QP, validation, DIT, 8D, 5M, 5S, Kaizen, LOTO) Metrology accreditation: calibration, verification, adjustment, settings: Temperature, pressure, conductivity, flowmetry Qualification: Validation of washing machines/detergent load cleaning, PPQ Autoclave, OQ on freeze-dryer loading system: use of VMP, Functional testing, URS data, HVAC tests, DCS compliance, load plans, Biological Testing, ACP testing, Pure Water tests, FDS.

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)

-Comparative study of experimental data of heat treatment curves with JMatPro software data -Study of correlations of Jominy test results with prediction data software