Ian S.
ɢxᴘ & ɪꜱᴏ Qᴜᴀʟɪᴛʏ | ᴀᴜᴅɪᴛᴏʀ | ᴅɪʀᴇᴄᴛᴏʀ at RRxCo.- Claim this Profile
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Bio
Credentials
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Principal (Lead) PQMS Auditor
IRCA | International Register of Certificated AuditorsFeb, 2016- Sep, 2024
Experience
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RRxCo.
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United Kingdom
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Biotechnology Research
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1 - 100 Employee
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ɢxᴘ & ɪꜱᴏ Qᴜᴀʟɪᴛʏ | ᴀᴜᴅɪᴛᴏʀ | ᴅɪʀᴇᴄᴛᴏʀ
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Sep 2022 - Present
RRxCo. | A Quality Partner for Life. RRxCo. is a solution provider that supports the Life Science industry with solutions to challenges within Quality. We support partners with Quality & Audit Services through to the Search & Selection of niche, hard to find skill-sets enabling you to hire the best talent in the market. +44 (0) 1256 961200 RRxCo. | A Quality Partner for Life. RRxCo. is a solution provider that supports the Life Science industry with solutions to challenges within Quality. We support partners with Quality & Audit Services through to the Search & Selection of niche, hard to find skill-sets enabling you to hire the best talent in the market. +44 (0) 1256 961200
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⭕ 𝗠𝗛𝗥𝗔 | 𝗙𝗗𝗔 | 𝗘𝗠𝗔 ⭕ 𝗜𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗼𝗻 𝗥𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝗻𝘁 ⭕
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Dec 2020 - Sep 2022
Mutiple Clients all within Life Sciene. One client in particular; Establishing readiness for the site and approval for licenced products into the USA. Development and implementation of Data Integrity Strategy and business roll out. Mutiple Clients all within Life Sciene. One client in particular; Establishing readiness for the site and approval for licenced products into the USA. Development and implementation of Data Integrity Strategy and business roll out.
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⭕ SME Auditor ⭕ - ✅ Regulated Industries (GxP & ISO) ✅
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May 2019 - Sep 2022
Inspection Readiness is a bespoke solution provider to clients who would like to achieve certification within Life Sciences, whether Pharmaceuticals💊, Biotechnology💉, MedTech❤️🩹 or ISO Regulated companies🏢. Creator of ⚙️ 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 𝗣𝗹𝗮𝗻 ⚙️ to help companies get and stay 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗲𝗱! 🟠Sterile & Non Sterile Environment (Pharmaceutical & Biopharmaceutical) 🔵Commercial & Clinical; API, Finished Product, ATMP, Packaging, Consumables, Excipients 🟠GMP, GDP, GLP, ISO, EXCiPACT 𝗧𝗿𝗮𝗰𝗸 𝗥𝗲𝗰𝗼𝗿𝗱 🔵 10+ Mock Inspections 🟠 5 Succesful FDA Pre-approval inspections 🔵 10+ FDA & MHRA Routine Inspections 🟠 120+ Supplier Assurance Audits 𝗖𝗼𝘂𝗻𝘁𝗿𝗶𝗲𝘀 𝗦𝘂𝗽𝗽𝗼𝗿𝘁𝗲𝗱 𝘄𝗶𝘁𝗵 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 🌎 EUROPE 🌍 UNITED STATES 🌏 ASIA 🌎 Show less
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FUJIFILM Diosynth Biotechnologies
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United Kingdom
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Biotechnology Research
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700 & Above Employee
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Quality Assurance Manager - Audit Group & Supply Assurance
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May 2003 - Aug 2020
📃Qualified Auditor📃 - Audit Group Manager GMP, GDP | ICH Q7 | ICH Q8 | ICH Q9 | ICH Q10 | ISO 🌎 MHRA | FDA | ANVISA | MFDS | TDMDI 🌎 Low-Bioburden - Early Clinical Phase to Commercial Manufacture (CDMO) 📃Qualified Auditor📃 - Audit Group Manager GMP, GDP | ICH Q7 | ICH Q8 | ICH Q9 | ICH Q10 | ISO 🌎 MHRA | FDA | ANVISA | MFDS | TDMDI 🌎 Low-Bioburden - Early Clinical Phase to Commercial Manufacture (CDMO)
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Officer
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Nov 2000 - May 2003
Audit inspection development plans supporting the audit programme for site GMP compliance and final release of sterile commercial product. Audit inspection development plans supporting the audit programme for site GMP compliance and final release of sterile commercial product.
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PPL Therapeutics
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United States
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Biotechnology
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1 - 100 Employee
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Quality Assurance Manager
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Jan 2000 - Nov 2000
Alpha-1 Antitrypsin Programme The company who cloned "Dolly" 🐑 Development and implementation of the site business QMS and system attributes supporting a business change from early phase drug development into phase I, II manufacture of clinical trial material, and including final Bulk Drug Substance batch release. Alpha-1 Antitrypsin Programme The company who cloned "Dolly" 🐑 Development and implementation of the site business QMS and system attributes supporting a business change from early phase drug development into phase I, II manufacture of clinical trial material, and including final Bulk Drug Substance batch release.
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Quality Assurance Officer
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Jan 1999 - Jan 2000
Audit inspection development plans supporting the audit programme for site GMP compliance and final release of sterile commercial product. Audit inspection development plans supporting the audit programme for site GMP compliance and final release of sterile commercial product.
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Education
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Bishop Auckland College
Toolmaker, Mechanical/Precision Engineering
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