I formed BioChem QP Consulting in 2010 after 15 years working for various pharmaceutical companies in Central Scotland. Originally from Birmingham, I graduated from the University of Edinburgh with BSc (Hons) in Chemistry in 1992. After completing my MSc in Instrumental Analytical Chemistry at Glasgow Caledonian University, I joined Zeneca in 1995, initially working in QC, supporting production of prostaglandin APIs. In 1998 I transferred to the Process Technology Department, performing API characterisation and analytical method development for GC, GC- MS, and HPLC - which has left me with an enduring interest in statistical data analysis and its many mis-uses. In 1999 I joined Quintiles Ltd (CRO & CMO) as a GMP QA Auditor, working closely with site QPs to support production and packaging of small molecule liquid and solid oral dosage forms (tablets and hard gelatin capsules) under Commercial, IMP, and Specials MHRA Licences. I was promoted to QA Section Head in 2000, and QA manager in 2003, with responsibility for the Clinical Trial Packaging & Distribution QA team. While at Quintiles I completed the University of Brighton Postgraduate Diploma in Industrial Pharmaceutical Studies (’QP Course’), while participating in company preparation for the implementation of the EU Clinical Trials Directive, and then acting as QP under the transitional arrangements for IMPs from 2004 onwards. In 2005 I joined the Contract Manufacturing Division of BioReliance Ltd, initially as QA  Manager and transitional QP, supporting production of cell / viral banks and biological IMPs (cell therapies, gene therapies, vaccines, biotechnology products) in the aseptic production facility. I obtained full QP eligibility on first assessment at the Royal Society of Chemistry in February 2006. From 2007 I focused solely on QP activities, preparing for the successful introduction of a commercial vaccine manufacturing project, which achieved MHRA approval in 2008, followed by FDA approval in 2009. During my career I have hosted / participated in over 20 MHRA & FDA inspections, countless client audits, and performed just about every task you could come across in pharmaceutical GMP QA, building a strong network of valued industry contacts along the way. Outside of work, I like nothing better than getting away with my family for a spot of beachcombing on the stunning coastline of Lochaber in the West Highlands of Scotland. When the sun is shining on the white sand and clear turquoise sea, you can briefly pretend you’re in the Caribbean, until you dip your toes in the water...

About BioChem QP Consulting Mark Slattery

BioChem QP Consulting Ltd. Registered Office 272 Bath Street, Glasgow G2 4JR Tel +44 (0)771 897 1245   email enquiries@biochem-qp.com