Experience

BPL Plasma

• United States
• Biotechnology Research
• 400 - 500 Employee

• Quality Assurance Operations

  • Oct 2018 - Present

  • Receive, review and process quality reports on Trackwise (eg: DR/CAPA records) according to define procedures. • Primary QA contact across site throughout shift and discern what is potentially a major or critical deviation. • Effectively involved in Root Cause Analysis for various deviations. • Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required. • Review Batch Processing Records and… Show more • Receive, review and process quality reports on Trackwise (eg: DR/CAPA records) according to define procedures. • Primary QA contact across site throughout shift and discern what is potentially a major or critical deviation. • Effectively involved in Root Cause Analysis for various deviations. • Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required. • Review Batch Processing Records and autoclave records. • Ensure a standard approach to quality systems throughout the facility, by undertaking both internal quality audits and QA inspections of facilities and activities, for departments across site. • Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and QA management. • Ensure that any documents presented for QA approval/checking are complete. • Effectively performed in pre-shutdown and Reinstatement shutdown inspection throughout the facility. • Performing AQL inspection of finished products as per ISO2859/BS6001. • Performing media/broth inspections. • Review and approval of Process Impact Risk Assessments. • Effectively involved in the preparation for MHRA and customer GMP audits. • Co-ordinate and maintain the files for a range of quality records as required. Show less • Receive, review and process quality reports on Trackwise (eg: DR/CAPA records) according to define procedures. • Primary QA contact across site throughout shift and discern what is potentially a major or critical deviation. • Effectively involved in Root Cause Analysis for various deviations. • Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required. • Review Batch Processing Records and… Show more • Receive, review and process quality reports on Trackwise (eg: DR/CAPA records) according to define procedures. • Primary QA contact across site throughout shift and discern what is potentially a major or critical deviation. • Effectively involved in Root Cause Analysis for various deviations. • Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required. • Review Batch Processing Records and autoclave records. • Ensure a standard approach to quality systems throughout the facility, by undertaking both internal quality audits and QA inspections of facilities and activities, for departments across site. • Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and QA management. • Ensure that any documents presented for QA approval/checking are complete. • Effectively performed in pre-shutdown and Reinstatement shutdown inspection throughout the facility. • Performing AQL inspection of finished products as per ISO2859/BS6001. • Performing media/broth inspections. • Review and approval of Process Impact Risk Assessments. • Effectively involved in the preparation for MHRA and customer GMP audits. • Co-ordinate and maintain the files for a range of quality records as required. Show less



Ransom Naturals Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Officer

  • Jan 2016 - Sep 2018

  • Review and release of raw material, bulk products and finished products. • Review and assessment of Deviations and CAPA’s and follow up department with actions and ensure to close them to meet the time line. • Review and approval of Change controls. • GMP and Deviation Investigations, including Root Cause Analysis investigations in conjunction with other departments. • Generation and monitoring of KPI’s. And reporting in the monthly board report. • Handling customer complaints… Show more • Review and release of raw material, bulk products and finished products. • Review and assessment of Deviations and CAPA’s and follow up department with actions and ensure to close them to meet the time line. • Review and approval of Change controls. • GMP and Deviation Investigations, including Root Cause Analysis investigations in conjunction with other departments. • Generation and monitoring of KPI’s. And reporting in the monthly board report. • Handling customer complaints and returned goods. • Risk analysis for all operations and processes as part of the RA team. • Performing Internal Auditing of Quality System and processes and follow up department with the audit observations. • Review and approval of process validation documents. • Review and approval of SOP’s, DOC’s, Analytical Specifications and Methods. • Review and approval of Supplier Specifications and associated documentation. • Review and approval of PQR’s. • Review and approval of New Material Supplier and Additional Material Supplier. • Collating and trending data for Quality systems i.e. Deviations, complaints, CAPA’s, Change Control, Validation. • Support the QA manager in assuring that the site is operated to the current GMP, GDP and BRC requirements for the product types manufactured. • Review and approval of Validation documentation (URS, IQ/OQ/PQ) for the key manufacturing equipments and QC systems like Ceramic Membrane System, CDS etc. • Performing weekly quality compliance checks in Quality control lab, warehouse and manufacturing departments. • Problem solving and root cause analysis of minor and complex issues, and taking corrective, preventive action for issues. • Keep line-manager informed of the status and progress of assigned projects in order to meet departmental objectives, identifying potential problems or delays, and possible solutions, as they occur. • Effectively involved in the preparation for MHRA and customer GMP audits. Show less • Review and release of raw material, bulk products and finished products. • Review and assessment of Deviations and CAPA’s and follow up department with actions and ensure to close them to meet the time line. • Review and approval of Change controls. • GMP and Deviation Investigations, including Root Cause Analysis investigations in conjunction with other departments. • Generation and monitoring of KPI’s. And reporting in the monthly board report. • Handling customer complaints… Show more • Review and release of raw material, bulk products and finished products. • Review and assessment of Deviations and CAPA’s and follow up department with actions and ensure to close them to meet the time line. • Review and approval of Change controls. • GMP and Deviation Investigations, including Root Cause Analysis investigations in conjunction with other departments. • Generation and monitoring of KPI’s. And reporting in the monthly board report. • Handling customer complaints and returned goods. • Risk analysis for all operations and processes as part of the RA team. • Performing Internal Auditing of Quality System and processes and follow up department with the audit observations. • Review and approval of process validation documents. • Review and approval of SOP’s, DOC’s, Analytical Specifications and Methods. • Review and approval of Supplier Specifications and associated documentation. • Review and approval of PQR’s. • Review and approval of New Material Supplier and Additional Material Supplier. • Collating and trending data for Quality systems i.e. Deviations, complaints, CAPA’s, Change Control, Validation. • Support the QA manager in assuring that the site is operated to the current GMP, GDP and BRC requirements for the product types manufactured. • Review and approval of Validation documentation (URS, IQ/OQ/PQ) for the key manufacturing equipments and QC systems like Ceramic Membrane System, CDS etc. • Performing weekly quality compliance checks in Quality control lab, warehouse and manufacturing departments. • Problem solving and root cause analysis of minor and complex issues, and taking corrective, preventive action for issues. • Keep line-manager informed of the status and progress of assigned projects in order to meet departmental objectives, identifying potential problems or delays, and possible solutions, as they occur. • Effectively involved in the preparation for MHRA and customer GMP audits. Show less



Tillomed

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Officer

  • Dec 2014 - Dec 2015

  • Expertise on Prepare, review and submit different type I variations to the competent authorities as per new legislation 1234/2008/EC. • Prepare and submit MA application in EU competent authorities by Common European Submission Platform. • Coordinate with EU competent authorities for special requirements for the MA application. • Prepare and submit change of ownership application to MHRA, • Gap-analysis of Scientific and technical data for variation submission in e-CTD… Show more • Expertise on Prepare, review and submit different type I variations to the competent authorities as per new legislation 1234/2008/EC. • Prepare and submit MA application in EU competent authorities by Common European Submission Platform. • Coordinate with EU competent authorities for special requirements for the MA application. • Prepare and submit change of ownership application to MHRA, • Gap-analysis of Scientific and technical data for variation submission in e-CTD format. • Prepare and submit RFI responses to the Health Authorities during the variation procedure. • Coordinates and prepares regulatory submissions for Safety Updates. • Liaising with various internal departments and competent authorities on all regulatory issues. • Assemble and submit renewal for MAA as per article 24 directive 2001/83/EC. • Coordinates and prepares regulatory submissions including MRP and National procedures • Actively contribute to cross-functional team working within the Medical, Pharmacovigilance, Artwork and other areas of the business. • Respond to medicinal information and pharmacovigilance queries regarding quality and safety of the company products. • Keep line-manager informed of the status and progress of assigned projects in order to meet departmental objectives, identifying potential problems or delays, and possible solutions, as they occur. • Responsible for archiving of regulatory files and documentation and maintenance of regulatory information. • Set up and maintain a complete, accurate and consistent database entry of records reflecting submission activity and keep up to date with changes in product licences and ensure that Tillomed products are compliant with the requirements. • Provide on job advice to members of the Regulatory Compliance Team; delegating work as appropriate, monitoring and managing performance. • Contributing to the achievement of local commercial objectives.

• QC Systems Leader

  • Nov 2013 - Nov 2014

  • Project co-ordinator of the implementation of iLAB system. • Performed risk analysis for the implementation of iLAB system in QC. • Co-ordinate with contract service provider for the yearly Calibration and preventive maintenance of the laboratory instruments. • Trouble shooting of issues with laboratory instruments. • Prepare PQR for the Tillomed products. • Handling of Deviations, Change controls, OOS and CAPA’s within quality control department. • Review of analytical data… Show more • Project co-ordinator of the implementation of iLAB system. • Performed risk analysis for the implementation of iLAB system in QC. • Co-ordinate with contract service provider for the yearly Calibration and preventive maintenance of the laboratory instruments. • Trouble shooting of issues with laboratory instruments. • Prepare PQR for the Tillomed products. • Handling of Deviations, Change controls, OOS and CAPA’s within quality control department. • Review of analytical data generated within the stability group, ensuring all results are documented according to cGMP. • Calibration of instruments such as HPLC, UV and Dissolution as per schedule. • Weekly updating for Quality documentation report (Ex: CAPA, OOS, OOT.and Deviation Report).



Bristol Laboratories Ltd.

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• QC Executive

  • Oct 2009 - Nov 2013

  • Project co-ordinator of the implementation of LIMS system. • Performed risk analysis for the implementation of LIMS system in QC. • Handling of Change control procedure, Deviation, CAPA and OOS. • Performing analytical testing using mainly HPLC, UV, Dissolution and FTIR for analysis of Pharmaceutical raw materials and finished products in compliance with standards of Good Manufacturing Practice • Experience in HPLC Troubleshooting. • Preparing and Reviewing of analytical… Show more • Project co-ordinator of the implementation of LIMS system. • Performed risk analysis for the implementation of LIMS system in QC. • Handling of Change control procedure, Deviation, CAPA and OOS. • Performing analytical testing using mainly HPLC, UV, Dissolution and FTIR for analysis of Pharmaceutical raw materials and finished products in compliance with standards of Good Manufacturing Practice • Experience in HPLC Troubleshooting. • Preparing and Reviewing of analytical reports in accordance with regulatory requirements. • Performing method transfer, method validation (as per ICH guidelines). • Good hands on experience in using HPLC interactive software like Total Chrom, Empower, LC Solutions, Lab Solutions, Chemstation. • Preparation of Finished Product specifications & Worksheets as per the Pharmacopoeia. • Ensuring the quality databases & documentation maintained with respect to EU GMP. • Chemical analysis of stability samples using a variety of techniques. • Review of analytical data generated within the stability group, ensuring all results are documented according to cGMP. • Calibration of instruments such as HPLC, UV and Dissolution. • Understand and follow all necessary Health & Safety systems. • Maintaining high standards of laboratory housekeeping in work area. • Have performed physical testing (friability, disintegration test, dimensions & hardness, weighing, loss on drying). • Effective management of samples for analysis. Show less • Project co-ordinator of the implementation of LIMS system. • Performed risk analysis for the implementation of LIMS system in QC. • Handling of Change control procedure, Deviation, CAPA and OOS. • Performing analytical testing using mainly HPLC, UV, Dissolution and FTIR for analysis of Pharmaceutical raw materials and finished products in compliance with standards of Good Manufacturing Practice • Experience in HPLC Troubleshooting. • Preparing and Reviewing of analytical… Show more • Project co-ordinator of the implementation of LIMS system. • Performed risk analysis for the implementation of LIMS system in QC. • Handling of Change control procedure, Deviation, CAPA and OOS. • Performing analytical testing using mainly HPLC, UV, Dissolution and FTIR for analysis of Pharmaceutical raw materials and finished products in compliance with standards of Good Manufacturing Practice • Experience in HPLC Troubleshooting. • Preparing and Reviewing of analytical reports in accordance with regulatory requirements. • Performing method transfer, method validation (as per ICH guidelines). • Good hands on experience in using HPLC interactive software like Total Chrom, Empower, LC Solutions, Lab Solutions, Chemstation. • Preparation of Finished Product specifications & Worksheets as per the Pharmacopoeia. • Ensuring the quality databases & documentation maintained with respect to EU GMP. • Chemical analysis of stability samples using a variety of techniques. • Review of analytical data generated within the stability group, ensuring all results are documented according to cGMP. • Calibration of instruments such as HPLC, UV and Dissolution. • Understand and follow all necessary Health & Safety systems. • Maintaining high standards of laboratory housekeeping in work area. • Have performed physical testing (friability, disintegration test, dimensions & hardness, weighing, loss on drying). • Effective management of samples for analysis. Show less