Regulatory Affairs and Pharmacovigilance Quality Assurance Enhanced With Appointment of Elaine Johnson to Spectrum Regulatory Solutions

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Spectrum Regulatory Solutions is pleased to announce the appointment of Elaine Johnson as Quality Assurance Manager, developing and maintaining the regulatory affairs consultancy’s quality management systems.

Spectrum Regulatory Solutions Enhances Quality Assurance With New Appointment

Spectrum Regulatory Solutions Enhances Quality Assurance With New Appointment

By ensuring compliance with legislation, guidelines and Standard Operating Procedures, Quality Assurance plays a vital part in ensuring the maintained safety of pharmaceutical and other products.

Spectrum Regulatory Solutions is pleased to announce the appointment of Elaine Johnson as Quality Assurance Manager, developing and maintaining the regulatory affairs consultancy’s quality management systems.

After a career as a registered nurse, Elaine Johnson moved into the pharmaceutical industry in 1998, working principally in the specialism of pharmacovigilance of medicines and the safety of biotech products. Before joining Spectrum, Elaine spent five years in pharmacovigilance consultancy, with primary responsibility for Quality Assurance and for the writing and quality review of procedural documents such as Standard Operating Procedures (SOP), Work Instructions and Detailed Descriptions of the Pharmacovigilance System (DDPS). Elaine holds a postgraduate diploma in Pharmacovigilance from the University of Hertfordshire.

“The role of Quality Assurance in regulatory affairs and pharmacovigilance is central to patient safety. By ensuring compliance with legislation, guidelines and Standard Operating Procedures, Quality Assurance plays a vital part in ensuring the maintained safety of pharmaceutical and other products.” said Angela Gisby, Managing Director of Spectrum Regulatory Solutions. “Particularly at this time, with the arrival of the new pharmacovigilance legislation in Europe, Elaine’s appointment is key to the support that we provide to clients seeking advice in this rapidly changing landscape.”

By appointing Elaine to the role of QA Manager, Spectrum benefits from her combined experience in Quality Assurance and in pharmacovigilance systems. At Spectrum, Elaine is responsible for the maintenance and development of the Company’s Quality Management System in line with Company SOPs and national/international legislation and standards. As well as managing internal systems and procedures, Elaine will be responsible for training and consultancy to clients facing regulatory and safety inspections.

"We're very pleased to welcome Elaine to our team" said Angela Gisby. "As Spectrum Regulatory Solutions continues to grow and undertake an ever-increasing throughput of projects, we must maintain the highest standards of accuracy and quality in the documentation we generate. This enables early intervention where potential issues may arise and enables implementation of appropriate corrective/preventative action."

About Spectrum Regulatory Solutions

Spectrum Regulatory Solutions has built a reputation for quality, reliable and responsive EU regulatory affairs consultancy services with major healthcare companies worldwide since 2005. The results speak for themselves: at least 70% of our business comes from repeat client work and referrals. Our rigorous approach builds quality into every project and assures compliance.
Spectrum Regulatory Solutions is part of the Zaicom International group of companies.

Press Contact: Ellie Coutts
Please call +44 (0)1403 320 280 for more information or interviews.

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