Thanks to my various experiences, I have a versatile profile in the pharmaceutical sector. I am looking for a position as CQV expert or process engineer.
Overview
8
8
years of professional experience
Work History
Project Coordinator - Automation / Process Control
RealDev
Brussels
11.2023 - Current
Projects management in industrial automation and digitalization, from study to production implementation, including the implementation of technical modifications and user training, with the aim of managing obsolescence, ensuring regulatory compliance, and optimizing production equipment for the pharmaceutical industry (Autoclaves, centrifuges, chromatography, Dry-Fog)
Management of subcontractors for installation or modification activities on GMP equipment (Work permits, operating procedures, LOTO, legal inspection, technical testing, investigation, calibration, maintenance)
Management of the CQV/CSV activities (Writing of protocols, execution of testing, updating of design documents with Kneat, Veeva and SAP)
Project management and tracking documentation update (Reporting, Tracking, KPIs, Planning, Risks & Issues), management of project meetings at different levels (from daily team meetings to sponsor meetings)
Project Leader / Process Engineer
UCB
Braine-l'Alleud
07.2021 - 06.2023
Writing and reviewing the documentation for the implementation of new equipment and processes for the aseptic filling of biological molecules (change control, URS, specifications, risk and impact analysis, FAT/development/validation protocols, reports, SOPs, deviations)
Developement of action plan to increase production capacity and process optimization linked to FDA audit
Task monitoring with different project SMEs and reporting of KPIs (Budget, planning, resource, deliverable, quality)
CQV Engineer - Process Equipment & CSV
Takeda
Lessines
05.2018 - 06.2021
Participation in the commissioning and validation of a new purification/formulation line for biopharmaceutical products (Skid UF/Vessels), and associated cleaning systems (CIP) and automated systems (PCS, SCADA, HMI, EBR)
Validation of cleanrooms and associated HVAC systems, storage areas and industrial freezers
Writing all V cycle documentation: Validation plan, URS, FDS, Design Review, risk analysis, IQ/OQ/PQ protocols, reports, deviations
Product & Process Engineer
GSK
Wavre
02.2017 - 03.2018
Development of a new agitation technology for mobile tank formulation of vaccines (FAT, commissioning, test result analysis)
Writing the documentation associated (URS, test protocols, reports, SOP for user/maintenance)
Management of technical testing and coordination of the project with internal and external stakeholders
Education
Certificate -
PRINCE2 Foundation
01-2021
Ecole De Biologie Industrielle
01-2017
Driver License
B
Languages
French
Bilingual or Proficient (C2)
English
Advanced (C1)
Espagnol
Intermediate (B1)
Timeline
Project Coordinator - Automation / Process Control
<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.<ul><li>Company Overview: Group Company of PUIG, Spain</li><li>Team Leadership & Process Excellence: Organised the transformation of the Finance & Accounts function, establishing performance-driven goals, and embedding a culture of accountability and continuous improvement. Drove operational efficiency through process redesigns, SOP implementation and optimal resource deployment, leading to measurable improvements in turnaround time and accuracy.</li><li>Strategic Partnering with CXOs: Acted as a key advisor to the CEO, CFO, and other CXOs on business planning, pricing strategies, and business model pivots to support scale-up and profitability. Contributed to investor communications with data-backed insights to enhance stakeholder confidence and secure strategic funding.</li><li>Cross-Functional & Global Stakeholder Management: Functioned as the strategic finance business partner to cross-functional heads and the PUIG global finance team, aligning local execution with global financial strategies and compliance requirements.</li><li>ERP Transformation & System Automation: Led end-to-end ERP reimplementation to address system gaps, enforce role-based controls, and automate core finance processes—resulting in enhanced data accuracy, faster reporting and improved internal controls.</li><li>Costing, Inventory & Profitability Optimization: Designed and implemented plant-level costing models to ensure accurate COGS determination. Improved inventory management across pricing, consumption tracking, and aging analysis—enabling better working capital control and cost efficiency.</li><li>Manufacturing Finance & Statutory Compliance: Supervised end-to-end accounting for manufacturing operations and ensured full statutory compliance.</li><li>Financial Reporting, MIS & Profitability Analytics: Delivered accurate and timely monthly MIS reports, including P&L, Balance Sheet and KPI dashboards with deep-dive variance analysis across stores, business verticals, and geographies. Supported board-level decision-making through insightful presentations on financial health and business performance.</li><li>Budgeting, Forecasting & Business Planning: Led the Annual Operating Plan (AOP) and rolling forecasts, ensuring alignment with strategic objectives and market dynamics. Monitored key financial metrics to enable business decisions and proactive cost management.</li><li>Statutory, Internal & Tax Audit Management: Finalized standalone and consolidated financials under Ind AS and IFRS, ensured timely group reporting and compliance with international standards. Delivered clean and timely closures of statutory, tax, and internal audits in coordination with Big 4 auditors. Strengthened audit readiness through pre-audit diagnostics and rectification of recurring control gaps.</li><li>Regulatory Compliance & Risk Management: Ensured end-to-end compliance which includes ROC, RBI, FEMA, Income Tax, GST, Transfer Pricing, DTAA, and Customs. Reviewed cross-border contracts and transactions to ensure arm’s length pricing, accurate TDS application, and proper documentation under Transfer Pricing regulations.</li><li>Commercial Negotiation & Contract Governance: Led commercial negotiations and structured deals with vendors and franchisees. Reviewed key business contracts to ensure financial viability, risk protection, and compliance with regulatory standards.</li><li>Treasury & External Commercial Borrowing (ECB): Managed fund planning and liquidity management including ECB drawdowns, bank negotiations, and interest optimization. Improved working capital cycles through proactive cash flow forecasting and receivables control.</li><li>Internal Controls & Governance Framework: Led organization-wide reviews of internal control systems, identified process gaps, and redesigned or implemented over 40 SOPs and IFCs. Established a governance structure for financial discipline, risk mitigation, and policy compliance across departments.</li></ul> at Kama Ayurveda Pvt. Ltd. & PUIG India Pvt. Ltd.
<ul><li>Profile: Record to Reporting (R2R)</li><li>Performing financial reporting and controlling for across all the entities (in Hyperion and Oracle = JD Edward).</li><li>Performing End to End P&L finalization (Review of accruals, Negative Cash Accrual, prepaid amortization schedule, FX Adjustments, creation, deletion and capitalization of fixed assets, posting of depreciation etc.) & taking calls with Controllers during Months end for further review of P&L.</li><li>Banking process includes positive pay exceptions, stop payment, voiding checks with AP team. Checks movement to unclaimed property. Payment proof, remittance details.</li><li>IFRS lease computation complying with IFRS 16 in CoStar – Real Estate Manager system (this is only for lease).</li><li>Preparation of webforms and variance analysis report and sharing with stakeholders with detailed information.</li><li>Performing Balance sheet reconciliation with adherence of policy and clearance of open items along with relevant details of lines which is overaged however will be staying for long time (i.e.- Bonus and dividends, Common Stocks, Security Deposits).</li><li>Facilitating team operations by discussions through the sharing of information and knowledge, identification of teamwork issues, development of problem-solving recommendations, and recommendations of standardizing team operations.</li><li>Cross train resources in order to have backup of each other to help team synergy helping team members to take leaves when required without bothering of work/process deliverables.</li><li>Conduct weekly, biweekly and monthly meetings with stake holders as per their agreement.</li><li>Create opportunities for team members to provide input on procedures/processes and share their expertise with other team members.</li><li>Working knowledge of ERP systems People Soft, ART (Reconciliation software of Oracle), JD Edward, Teradata, Cetova, Hyperion (HFM), Cadency, Blackline, SAP, NetSuite, Workday Adaptive, Coupa, Tableau, CoStar, Alteryx.</li><li>PROCESS IMPROVEMENTS</li><li>Given 12 lean ideas in area of Month End Close journals, Balance Sheet Reconciliations, and Bank Reconciliations.</li><li>Part of a green belt project on quality of reconciliations and BOT implementation (work in progress) – controllership impact</li><li>Bring automation & Marco enabling dash board MIS reporting for monthly SLA, KPI, IC balances, Cash forecasting etc.</li></ul> at Genpact India Pvt. Ltd<ul><li>Profile: Record to Reporting (R2R)</li><li>Performing financial reporting and controlling for across all the entities (in Hyperion and Oracle = JD Edward).</li><li>Performing End to End P&L finalization (Review of accruals, Negative Cash Accrual, prepaid amortization schedule, FX Adjustments, creation, deletion and capitalization of fixed assets, posting of depreciation etc.) & taking calls with Controllers during Months end for further review of P&L.</li><li>Banking process includes positive pay exceptions, stop payment, voiding checks with AP team. Checks movement to unclaimed property. Payment proof, remittance details.</li><li>IFRS lease computation complying with IFRS 16 in CoStar – Real Estate Manager system (this is only for lease).</li><li>Preparation of webforms and variance analysis report and sharing with stakeholders with detailed information.</li><li>Performing Balance sheet reconciliation with adherence of policy and clearance of open items along with relevant details of lines which is overaged however will be staying for long time (i.e.- Bonus and dividends, Common Stocks, Security Deposits).</li><li>Facilitating team operations by discussions through the sharing of information and knowledge, identification of teamwork issues, development of problem-solving recommendations, and recommendations of standardizing team operations.</li><li>Cross train resources in order to have backup of each other to help team synergy helping team members to take leaves when required without bothering of work/process deliverables.</li><li>Conduct weekly, biweekly and monthly meetings with stake holders as per their agreement.</li><li>Create opportunities for team members to provide input on procedures/processes and share their expertise with other team members.</li><li>Working knowledge of ERP systems People Soft, ART (Reconciliation software of Oracle), JD Edward, Teradata, Cetova, Hyperion (HFM), Cadency, Blackline, SAP, NetSuite, Workday Adaptive, Coupa, Tableau, CoStar, Alteryx.</li><li>PROCESS IMPROVEMENTS</li><li>Given 12 lean ideas in area of Month End Close journals, Balance Sheet Reconciliations, and Bank Reconciliations.</li><li>Part of a green belt project on quality of reconciliations and BOT implementation (work in progress) – controllership impact</li><li>Bring automation & Marco enabling dash board MIS reporting for monthly SLA, KPI, IC balances, Cash forecasting etc.</li></ul> at Genpact India Pvt. Ltd
<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group