TMQA Latest News

EC, EMA and WHO Step up Cooperation to Better Protect Global Public Health

The EC and the EMA have agreed with the World Health Organisation (WHO) to share certain non-public information on the safety, quality and efficacy of medicines already authorised or under review in the European Union, or pre-qualified or under review by WHO. This cooperation will strengthen communication between the respective organisations and make it easier to protect public health. Under the confidentiality arrangement, the organisations involved may share information such as:

  • Post-authorisation pharmacovigilance data, particularly related to adverse drug reactions as well as safety concerns arising from periodic safety update reports, and post-authorisation obligations and commitments.
  • Information in applications for scientific advice, orphan medicine designation, marketing authorisation or post-authorisation activities of significant public health interest and applications for agreement of paediatric investigation plans.
  • Data related to inspections, manufacturing facilities and clinical research activities and related reports.

This cooperation between the organisations started on 01 September 2015.  http://tinyurl.com/ngmwhcf


TMQA exhibit at the BioCity Nottingham Lab Services Fair

Andrew and Adele attended the BioCity Nottingham Lab Services Fair today.   It was a great event with a real buzz and we met some really interesting companies.



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
Read More »

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.

Interested?

Please send your curriculum vitae to careers@tmqa.co.uk or send us a message if you would like more details or an informal chat about the job.