Scotland’s latest proposed Enterprise Area – the BioCity industrial tech incubator – could see employment boosted by another 180 new jobs in the next five years. Read more at http://www.biocity.co.uk/news/scotland/2015/first-minister-announces-new-enterprise-area-at-biocity-scotland
TMQA Regulatory News Update - August 2015
Download this month`s TMQA Regulatory News Update to find out more about:
- MHRA GPvP Inspections of Contract Service Providers
- Draft Addendum to ICH E6 Released
- EMA launches pilot in relation to Post-Authorisation Safety Studies
- MHRA enforces EC decision in relation to GVK Biosciences
- EMA revises guidelines on implementation of fast track routes for medicines that address unmet medical needs
Quality Assurance Associate - Career Development Opportunity
TMQA continues to grow and we are looking for a new Associate. This is a career development position for those with 2+ years’ experience working with GLP / GMP / ISO 17025.
Quality Assurance Associate
TMQA is a leading international Quality Assurance organisation providing consultancy, training and audit to life science and related companies. There is a vacancy for an Associate to join our pre-clinical team.
About the Job
The successful candidate will work with other members of the pre-clinical team to provide Quality Assurance support to our clients, who range from major international organisations to local start-up companies and academic groups. This will involve reviewing their quality systems and documentation, inspecting facilities and processes and providing advice and guidance in the development of their quality management systems.
Most of the work will be local to our Edinburgh office but there may be a requirement for travel which can involve being away from the office overnight. This job will particularly suit people who are interested in science but don’t want to work at the bench and it offers significant career development opportunities.
What we are Looking For
Candidates must have a degree in a relevant subject (e.g., Chemistry or Life Sciences) and experience of working with GLP, GMP and/or ISO 17025. Ideally this would be in a QA role but we would like to hear from candidates who are interested in QA as a profession.
Particular characteristics we are looking for include:
· Attention to detail;
· Good written and verbal communication;
· Ability to interact with client staff;
· Ability to work independently as well as in a small team;
· Working knowledge of WORD and EXCEL.
Knowledge of a second language and a full driving licence would be beneficial.
Please send your curriculum vitae to email@example.com or send us a message if you would like more details or an informal chat about the job.
Gráinne Forrest joins TMQA as a Principal Associate (GCP)
TMQA is pleased to announce that Gráinne Forrest will join TMQA as a Principal Associate (GCP) at the beginning of August. Gráinne was most recently the Regional Director (EU) for Medpace and before that she was QA Director for Clintec International for nearly four years. Previously Gráinne has also worked for ADAMAS Consulting, Charles River and Q One Biotech.
Launch of Yellow Card Smartphone App
The Yellow Card Scheme was launched in 1964 following the Thalidomide disaster to monitor the safety of UK medicines and act as an early warning system to identify potential side-effects and adverse reactions. The scheme is run by the MHRA who collate and review reports of suspected adverse drug reactions on all licensed and unlicensed medicines and vaccines. Yellow Cards are used, alongside other scientific safety information to help the MHRA make changes, if necessary, to the warnings given to people taking a medicine or vaccine, or to the way they are used, to minimise potential risks. A new Yellow Card smartphone app has been launched this month for people to report problems with medicines. It provides a convenient alternative to using paper Yellow Card forms or the Yellow Card website. It is the only app that allows patients, carers and healthcare professionals to report side effects directly to the Yellow Card Scheme. Users can select specific medicines or vaccines to track and receive news and alerts about them. The app has been created in collaboration with the Innovative Medicines Initiative WEB-RADR project – a large-scale, public-private partnership between the European Commission, national regulatory authorities, academia, small and medium-sized enterprises and the European Federation of Pharmaceutical Industry Associations (EFPIA) that aims to boost biopharmaceutical innovation. The app is free to use for anyone on iOS and Android. http://tinyurl.com/pgo4yfc