Junior Papalii

• Management of our site's Integrated Management System (ISO 9001, ISO 45001, ISO 14001).
• Plan and complete internal audits under all three standards, manage external audits and corporate audits.
• Analyse KPIs for safety and quality, and present findings to the management team.
• Investigate and manage NCRs on site, with weekly review meetings to monitor progress and findings.
• Complete supplier audits and evaluations to ensure external parties comply with the standards and Sandvik requirements.
• Conduct weekly reviews of hazards and incidents with management and supervisors, ensuring appropriate actions are taken to address issues raised.
• Plan, complete, and coordinate on-site external and internal training, ensuring records are maintained and up to date for compliance and audits.
• Advise management on legislative requirements, identify gaps in the business, and develop action plans to ensure the business remains compliant with current regulations.
• Manage consultation meetings with the workforce, liaising with staff to address safety issues and concerns, and presenting findings to management with guidance on appropriate actions to ensure a healthy and safe work environment.
• Oversee contractor management, ensuring the site has a contractor management process in place, and that all contractors are inducted, SWMS are provided, and insurances are reviewed for compliance.
• Update all procedures to align with current legislative requirements and reflect current practices.
• Maintain all documents in accordance with the standards.
• Conduct staff training sessions.
• Monitor KPIs and prepare reports.
• Drive safety and Quality Improvements.

• Oversee the Safety Management System, including conducting internal safety audits and driving safety improvements
• Coordinate both internal and external safety training programs
• Develop and author Standard Operating Procedures (SOPs) for general safety and equipment safety
• Ensure SOPs are current and compliant with relevant standards and legislation
• Provide training and education on safety protocols and legislative updates, updating procedures accordingly
• Maintain an up-to-date database to ensure compliance with all regulatory requirements and standards
• Facilitate monthly safety meetings to discuss safety issues and project updates
• Review and complete permits, risk management systems, and risk assessments
• Conduct Gemba walks within the factory to verify safety compliance and identify opportunities for process improvements to reduce safety risks.
• Manage the company's Quality Management System in accordance with ISO 9001 standards
• Plan and schedule internal audits and oversee external audits conducted by Veritas
• Author and review all SOPs, including the quality manual, to ensure alignment with current business practices and objectives
• Organise and lead management review meetings to evaluate the progress of the quality management system
• Maintain KPIs such as DIFOT and quality objectives
• Manage and resolve Non-Conformance Reports (NCRs) both internally and externally, utilizing root cause analysis and implementing corrective and preventive actions
• Collaborate with departmental heads to improve quality systems, implement changes, and provide training on new processes and standards

• Review production batch documents to ensure compliance with site SOPs, cGMP, quality standards, and regulatory requirements prior to QA review.
• Resolve discrepancies in batch documentation promptly by liaising with the production team to ensure errors are corrected, enabling timely release of products for bulk vaccine manufacturing.
• Manage SOPs, Points of Interest (POIs), Deviations, and CAPAs, ensuring they are completed within deadlines and maintaining First Time Right (FTR) figures.
• Prepare areas for internal and external GMP, USDA, and corporate audits.
• Conduct complex product deviation investigations to prevent product discards, identifying root causes and implementing appropriate CAPAs, in collaboration with QA, QC, Engineering, and Compliance departments.
• Implement and update SOPs to reflect current practices and improve workflow within manufacturing areas.
• Complete CAPAs ahead of deadlines, ensuring adherence to FTR targets.
• Assist in scheduling antigen manufacturing and shift rosters.
• Provide technical expertise in manufacturing to enhance safety and quality standards.
• Chair Tier 1 meetings each morning to discuss safety risks, safety notes, and new directives.

• Worked in Fermentation, IPT and Seeding Production areas, growing anaerobic and aerobic bacteria

to produce toxins to be later converted into toxoid.

• Training new staff on how to operate equipments and follow processes using SOP's.
• Working in IPT, performing pH measurements, Turbidity meter, microscope usage and gram staining

and plating on tas-agar and Blood agar plates under biohazard cabinet.

• Working in Glove box, inoculating broths with nitrogen store seeds.
• Working with Seed Fermenters and Production Fermenters.
• Promptly documented and reported all defective equipment and hazardous conditions.
• Calibrated machines to maintain required productivity levels and adherence to quality standards.
• Trained and supervised production personnel to properly use production equipment and apply best practices all while adhering to GMP practices.

• Worked in Media Preparation and Centrifuge Production areas, ensuring adherence to GMP standards and safety protocols.
• Prepared media according to production schedules, accurately dispensing raw materials and chemicals into vessels while maintaining proper documentation.
• Trained new technicians on media preparation and centrifuge operation to ensure consistent process compliance.
• Operated centrifuge machines to separate cells from culture broth, followed by filtration into ultrafiltration vessels for further processing.
• Monitored and adjusted process parameters to optimize yield and product quality throughout production.
• Conducted routine equipment maintenance, cleaning, and calibration to ensure optimal performance and compliance with regulatory standards.
• Completed all necessary documentation, including SOPs, deviations, CAPAs, and OFTs, maintaining accurate records for batch traceability and audit readiness.
• Participated in process validation activities and contributed to continuous improvement initiatives to enhance operational efficiency.
• Ensured proper waste disposal and environmental controls were followed in accordance with safety and environmental regulations.

• Executed scheduled packing operations in accordance with relevant SOPs, ensuring accuracy and compliance throughout the process.
• Trained technicians on the operation of packing equipment, adhering to SOP guidelines to maintain process consistency and quality.
• Completed all required documentation in accordance with cGMP and GDP standards to ensure traceability and regulatory compliance.
• Managed deviations, CAPAs, and SOP authoring and review within the packing area to support continuous improvement and compliance.
• Reviewed batch records meticulously to ensure accuracy and completeness prior to product release.
• Reconciled all labels and documentation, and prepared line clearances to prevent batch contamination and ensure process integrity.
• Conducted equipment inspections and maintained cleanliness of the packing area to uphold hygiene standards.
• Assisted in process validations and participated in quality audits to ensure adherence to regulatory requirements.

• Executed scheduled packing operations in accordance with relevant SOPs, ensuring accuracy and compliance throughout the process.
• Trained technicians on the operation of packing equipment, adhering to SOP guidelines to maintain process consistency and quality.
• Completed all required documentation in accordance with cGMP and GDP standards to ensure traceability and regulatory compliance.
• Managed deviations, CAPAs, and SOP authoring and review within the packing area to support continuous improvement and compliance.
• Reviewed batch records meticulously to ensure accuracy and completeness prior to product release.
• Reconciled all labels and documentation, and prepared line clearances to prevent batch contamination and ensure process integrity.
• Conducted equipment inspections and maintained cleanliness of the packing area to uphold hygiene standards.
• Assisted in process validations and participated in quality audits to ensure adherence to regulatory requirements.