Melisa Tigli

Continuous Improvement Lead with pharmaceutical manufacturing experience in a GMP-regulated environment. Hands-on experience with automated and semi-automated manufacturing equipment, equipment size changes, minor maintenance and troubleshooting, combined with experience in controlled documentation, investigations, validation support, data analysis and cross-functional improvement projects. Experienced in SAP, IFS, LIMS and TrackWise, with a strong focus on Good Documentation Practices, process standardisation, controlled change and stakeholder coordination.

Brings a practical production perspective to maintenance and asset-related activities and is motivated to apply this experience within a structured maintenance and asset coordination environment.

Continuous Improvement Lead (Seconded) - Kedrion Biopharma - Elstree UK

(2025-05)

• Deliver progress updates on projects and tasks, ensuring activities and changes are communicated to relevant internal and external stakeholders in a timely manner.
• Develop progress reporting for Senior Leadership Team (SLT) review, providing visibility of project status, actions and improvement activities.
• Review production processes to identify constraints and obstacles and work with stakeholders to minimise or eliminate them.
• Identify activities requiring controlled changes and update procedural documentation to support compliant and standardised ways of working.
• Liaise with internal and external stakeholders to implement production process improvements in a GMP-regulated manufacturing environment.
• Support supplier quality defect investigations by extracting and consolidating SAP data covering material codes, lot numbers, descriptions, pack sizes, stock quantities and locations.
• Develop and standardise operational documentation, including a Line Trial template and an SOP for setup and operation of the Domino M-Series printer.
• Support configuration and operational activities for production-line Vision and Domino printing systems.
• Validation Project Support — supported execution and documentation activities including peer review and preparation of IOQR and VMPR reports.
• Delivered the construction and installation of three inspection booths and implementation of new room G32A.
• Implemented and aligned Elstree site with business services onto packing / training lines from GoToAssist to Beyond Trust.
• Introduced Smart Lockers for the delivery and collection of final product samples to enable efficient processing and traceability.
• Updated CF labels to eliminate peeling replaced 76mm to 100mm reel core.
• Introduced cutter profiles on front / rear cartons and designated patterned area to improve locking mechanism, TESS application, overprinting for a secure integrity.
• Reduced label reel quantities from 5,000 to 3,000 to better align material quantities with production requirements after reviewing five years of packing yield.
• Supported and executed activities involving new GTINs and MPIs in TraceLink and updates to production packing-line Vision systems for Coagadex EU MAH and Serialisation Changes.
• Coordinated Quality, Production, Serialisation and Warehouse stakeholders to establish and document the rework process for damaged shipper cases.
• 622GB of Optel backup data to a centralised server location to improve organisation and accessibility of system records.

Production Technician - Kedrion Biopharma - Elstree UK

(2023-01 - 2025-05)

• Developed practical understanding of mechanical equipment and performed equipment size changes and minor maintenance tasks.
• Set up and operated automated and semi-automated manufacturing equipment in accordance with approved procedures and agreed production programmes.
• Troubleshot equipment issues and carried out simple maintenance activities to support production operations.
• Worked with systems and equipment that were maintained and calibrated, supporting compliant manufacturing operations.
• Reviewed SOPs, BPRs and related controlled documentation and supported specific investigations.
• Manufactured products in compliance with approved procedures within a GMP-regulated environment.
• Supported stock control and maintained awareness of equipment, materials and production requirements.
• Delivered and supported the transition period from IFS to SAP by updating case-label SKU configurations from 8-digit to 10-digit values and revising production recipes to align with SAP logistics requirements.
• Supported execution of the Optel Test Line IOQ following identification of incorrect serialisation codes during validation testing.
• Supported RCA investigation of missing Mandarin characters and licence information and coordinated with China representatives and delivered implementing over-labelling solution on identified batches.

Support / Admin Worker - Grace Health & Social Care - Bolton

(2022-08 - 2022-09)

Provided administrative and support assistance, including information presentation, document accuracy and accessibility, and communication with internal and external stakeholders.

BA (Hons) - Illustration and Visual Media - University of the Arts London, London College of Communication (2019 - 2022)