January 2013 -- CONTRACT development and manufacturing organisation (CDMO) SCM Pharma has bolstered its quality department and board with the appointment of a new Qualified Person (QP).
Senior quality professional Mark Edwards joins the UK-based company as Quality Assurance Director to manage the QC function and be responsible for quality across the organisation’s three sites.
Highly-experienced Mark has spent over 30 years in the global pharmaceutical and biotech industry having worked with the likes of Merck, Abbot and Fujifilm and becomes the third QP at SCM Pharma.
He brings extensive knowledge of quality systems, a variety of different dosage forms, production management and the undertaking of the preparation for pre-approval inspections and other regulatory authorities to his new role.
Dianne Sharp, managing director at SCM Pharma, said: “There are hugely important quality requirements around the sterile manufacturing and filling of drugs so we need to always ensure we have the right level of expertise and resource to meet the regulatory requirements.
“At present, almost a third of our entire workforce sits within the quality function, which demonstrates our commitment to achieving the highest quality standards across our development, clinical trial supply and commercial production operations.
“Mark is an exceptional addition to our board of directors given his background in quality and will bring a great deal to our clients’ projects in terms of ensuring quality systems are robust, manufactured products are fit for purpose and the efficient release of products.”
The CDMO specialises in the sterile production of products for clinical trials along with the supply of licensed drugs in niche markets. It is currently gearing up for the opening of its new commercial facility that will reinforce its expertise in vial, ampoule and syringe filling, particularly when dealing with highly potent and toxic products that require aseptic processing using isolator technology.
SCM Pharma’s newly appointed quality assurance director Mark Edwards said: “I am delighted to be joining such a dynamic and reputable manufacturer such as SCM Pharma. I’ve worked with many pharma companies over the years and my aim here is to develop quality metrics so they help drive the right behaviour that supports the business in its delivery of finished products.
“I am looking forward to the challenge of simplifying systems whilst remaining compliant but at the same time making them more efficient and future proofing them to withstand increasing volumes and up and coming legislation.
“Already I’ve been really impressed by the can-do attitude from the staff along with a complete package of development work through to the to commercial manufacture of finished dosage forms including terminally sterilised and aseptically filled products.”
A QP since 1992, Mark has undertaken a Post Graduate Diploma in Industrial Pharmaceutical studies at Brighton University, Mark is also a Graduate of the Society of Biology specialising in Microbiology from the North East Surrey College of Technology and a Fellow of the Institute of Biomedical Sciences from Paddington College, London.