Shivam Desai

• ·Reviewed batch manufacturing records (BMRs/BPRs) to ensure accuracy, completeness, and compliance with cGMP standards.
• Performed daily QA floor walkthroughs to monitor operations and ensure alignment with SOPs and regulatory expectations.
• Contributed to continuous improvement initiatives by identifying trends in quality events and supporting process optimization efforts.
• Managed and reviewed controlled documents within Veeva QualityDocs, ensuring version control, approval workflows, and compliance with regulatory requirements.
• Managed controlled documents using systems like Veeva or MasterControl, including SOPs, forms, and protocols.
• Identified trends in deviations and CAPAs to drive continuous improvement initiatives
• Performed aseptic setup, calibration, and operation of 500L stainless steel and/or single-use bioreactor systems for upstream processing.
• Operated and monitored Tangential Flow Filtration (TFF) systems for concentration and diafiltration of biologics.
• Performed system setup, buffer preparation, membrane integrity testing, and clean-in-place (CIP) procedures for TFF units.
• Aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substance using Moderna specific technologies including chromatography, multiple filtration methods and nano-mixing operations.
• . Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
• · Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• · Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.
• · Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
• · Understands physical and digital systems governing equipment and processes to enable basic troubleshooting.
• · Filling and dispensing activities to final container closure for finished clinical and commercial drug substance prior to forward processing.
• · Able to approve document revisions as delegated by their manager.

● The Pharmaceutical Operator will operate the equipment to manufacture client pharmaceuticals and repair/maintain equipment as necessary.

• Reviewed batch manufacturing records (BMRs/BPRs) to ensure accuracy, completeness, and compliance with cGMP standards.
• Initiated and supported investigations for deviations, ensuring timely documentation, root cause analysis, and implementation of effective CAPAs.

● Maintenance of calibration logs/status and upkeep of material calibration

● Ensuring sufficient stock levels are maintained for machine consumables/area consumables such as Hepa filters

● Performance of IQ/OQ for new equipment where required

● Ensuring sufficient stock levels of consumables and appropriate PPE are kept

● Production of risk and COSHH assessments for activities undertaken within the area

● Maintenance and updates to Production Checklists where necessary

● Waste disposal of Pharma waste and solvent waste

● Working in a Health & Safety conscious manner following safe systems of work

● Project Specific manufacturing activities, including room set-up, production, packing, room clean down, label production, checking, and other associated activities

● Production of working protocols, or batch documentation for production exercises in line with standard ways of working within the department

● Ensuring all documents are checked and approved prior to undertaking production exercises

● Recording all production undertakings in line with GMP and completion of all documentation to achieve a ‘right first time’ standard of work. In line with SGS Quay’s OP’s and to report any deviations through SGS Quay’s quality system

● Reporting where required in standard SGS Quay Pharma format in line with SOP’s/standard ways of working

working

● Executed routine manufacturing assignments according to written procedures with minimal instructions

● Proficiency in documenting manufacturing processes, including batch records, SOPs, and logbooks.

● Familiarity with Good Manufacturing Practices (GMP) and regulatory guidelines specific to the biopharmaceutical or biotechnology industry. Knowledge of FDA regulations and guidelines is often necessary

● Assume responsibility for overseeing and regulating the inventory levels of materials and components.

● Ability to analyze process data, perform calculations, and interpret results accurately.

● Running and handling automatic machines in the cleanroom.

● Prepare a media solution for bacterial growth.

● Troubleshooting problems and errors on the automation machine.

● Calibration check on systec media.

● Practice and followed cGMP.

● Process document data through batch records.

● Worked on Systec media development.

● Final inception of cassettes and approved for packaging.

● Practice and followed cGMP.

● Inspected finished products for quality and adherence to customer specifications.

● Performing in process inspection of CMM.

● Developed and maintained courteous and effective working relationships. ● Worked on KDF, SUSS, Top Coat, Base Coat.

● Trains for proficiency in the operation of primary production equipment within the assigned functional area (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.).

● Performing shipping task from sales order to dispatching

● Provided needed support to team leads and supervisors complete documentation.

● Kept production logs and maintained job material inventory.

● Replenished condiments, beverages, and supplies while maintaining the cleanliness of service areas.

● Audit of machine before production starts up.

● Checked completed orders for accuracy and bagged meals for easy carrying.

● Working with senior management to manage large and complex production tasks.

● Assisted management with inventory control and stock ordering.

● Reported non-conforming results and trends to supervisor for corrective action