𝗥𝗥𝘅𝗖𝗼. | A Quality Partner for Life. Not just your average Consultancy. 𝗥𝗥𝘅𝗖𝗼. is a solution provider that supports the Life Science industry with challenges within Quality. We support partners with Quality & Audit Services through to Search & Selection of niche, hard-to-find skill-sets enabling you to engage the best talent in the market. +44 (0) 1256 961200www.rrxco.com🔹𝗧𝗛𝗜𝗥𝗗-𝗣𝗔𝗥𝗧𝗬 𝗚𝘅𝗣 & 𝗜𝗦𝗢 𝗔𝗨𝗗𝗜𝗧𝗦🔹API, Raw Materials, Consumables, Clinical Investigator Sites, Contract Laboratories, CDMO/CMO, Licensing Partners, etc... 🔹𝗦𝗘𝗔𝗥𝗖𝗛 & 𝗦𝗘𝗟𝗘𝗖𝗧𝗜𝗢𝗡 (Perm & Contract Recruitment)🔹 Quality Assurance (QA), Quality Control (QC), CMC, Process Development, MS&T, Project Management🔹𝗤𝗨𝗔𝗟𝗜𝗧𝗬 𝗦𝗘𝗥𝗩𝗜𝗖𝗘𝗦🔹Mock Inspection, Pre-Approval Inspection, GxP & ISO Training, QMS Development, Quality/Site Harmonisation

EQA provides supplier quality services to biological and chemical pharmaceutical and life science organisations that require support with Quality Improvement activities and GxP/ISO Supplier and Third Party audits.

• Represented Quality for FDBK on the Global introduction of SAP S/4 Hana• Trained and tracked the training of all Quality users and super users in the utilisation of SAP S/4 Hana• Created, revised, reviewed, or facilitated all SOPs and Work Instructions for all departments and functions impacted by changes due to SAP Hana implementation• Operated as both Backroom manager and support roles for client audits• Performed internal and supplier audits• Executed and facilitated Supplier risk assessments to enable global audit scheduling

• Created KPI s and associated trackers and dashboard for Supply Assurance • Review and approval of Raw Material and Consumable specifications• Logging, assessment, and communication of External Change Notifications to relevant departments within Fujifilm• Supplier approval for Vendors, Suppliers, Manufacturers and Service Agents• Regular meetings with Supply Chain to evaluate Vendor Complaints and perform Vendor Reviews• Completion of TSE Certification as required for disposition• Release of consumables and raw materials via SAP• Maintain and update approved tracker spreadsheets• Investigate and assess events, deviations and CAPAs• Update and review work instructions and standard procedures as required• Coach and train others in Vendor Assurance principles

• Performing analysis of raw materials, IPCs, intermediates and final products to cGMP standards• Training new starters and apprentices in all aspects of the QC laboratory, including analytical techniques and quality documentation• Checking of other analyst’s worksheets and data• Writing and implementation of quality procedures and analytical methods• Routine calibration and maintenance of equipment• Method development of novel and existing analytical HPLC and GC methods• Responsible for stock control and ordering of all laboratory consumables

• Assisted the QA Manager in building, maintaining and managing an efficient, well trained and effective cGMP Quality Assurance Management system• Responsible for reviewing, developing and evaluation of SOP’s and the QMS ensuring compliance with MHRA and FDA regulations• Investigating OOS results and deviations within GMP manufacturing and analysis• Involved in the qualification, validation and re-qualification of equipment, including HPLC, GC, GCHS, NMR, FTIR and KF.• Performed supplier approval audits by questionnaire ensuring compliance to regulations• Assisted with internal audits on the QMS verifying adherence cGMP regulations

• Conducted analysis of raw materials through to final API to a high standard of cGMP• Responsible for updating, streamlining and checking of quality SOP’s within the AC department ensuring compliance with MHRA and FDA regulations• Performed OOS investigations to ascertain the cause of anomalous results, reporting the outcome via SAP• Involved in the qualification, validation and re-qualification of equipment• Successfully transferred methods from an external supplier to the internal laboratory

• Performed testing of inhalers, drug substances and stability samples by means of HPLC and ACI to cGMP standards• Initiated and investigated laboratory deviations

• Analysed new drug compounds and excipients produced by novel synthesis processes using HPLC, ACI, KF, UV and FTIR spectroscopy• Involved in method development for the ACI and HPLC analysis of new formulations and innovatively prepared API’s• Successfully completed a Year in Industry project involving solubility studies of active pharmaceuticals and carrier molecules

• Performed analysis of many different drug substances, active powders, gels, suspensions, tablets, capsules, and liquids to a high standard of cGLP