Scientific Administrator - Manufacturing & Quality Compliance

A large EU Agency based in Canary Wharf are looking for a Bilingual Scientific Administrator to join the Manufacturing & Quality Compliance service within the Inspections and Human Medicines Pharmacovigilance division. The role will be a 10.5 month interim contract to start immediately. This is a great opportunity to use your scientific and administrative skills in an EU Institution that provides a truly international working environment where everyone is passionate about public health.

Duties will include Meeting Support and International collaboration, Market Surveillance and Inspection Coordination and Procedural Support. You will be responsible for:

• Secretariat support to GMDP IWG, Compliance Group/JAP, QWP, PAT team and HMPC drafting group, MRA, PIC/s liaison, APEC Road Map and ICMRA.
• Contribution to the development of documents by the GMDP Inspectors Working Group, or Quality Working Party as needed.
• Secretariat support to GMDP IWG sub-meetings including Blood Inspectors meetings, quality defect contact point meetings and other meetings that may arise from time to time.
• Co-ordination of assessment of quality defects and recalls within the Agency and within the EU regulatory Network and with international partners when required.
• Co-ordination of assessment of reports of non-compliance with GMP from EU or international partners.
• Co-ordination of Sampling and Testing programme for centrally authorised products including pre-authorisation and post-authorisation activities.
• Co-ordinating pre-approval and post-approval GMP inspections.
• Validation of initial applications and line extensions (GMP Part H/V).
• Validation of type II variations (GMP Part H/V).
• Co-ordination of PMF inspections.

The working languages of the organization are; Spanish, Czech, Danish, German, Estonian, English, French, Italian, Latvian, Lithuanian, Hungarian, Maltese, Dutch, Polish, Portuguese, Slovenian, Slovakian, Finnish, Swedish, Greek, Romanian, Bulgarian, Croatian, Norwegian, Icelandic.

Profile

• Fluency in English and another EU language
• Degree in Pharmacy or Life Sciences
• Excellent communication skills
• Advanced IT skills
• Fluency in English and at least one other EU language -Spanish, Czech, Danish, German, Estonian, English, French, Italian, Latvian, Lithuanian, Hungarian, Maltese, Dutch, Polish, Portuguese, Slovenian, Slovakian, Finnish, Swedish, Greek, Romanian, Bulgarian, Croatian, Norwegian, Icelandic

To apply, please send your CV in Word format to Rebecca. If you have applied for any other languagematters vacancy there is no need to re-apply, as your CV will be considered for all language jobs that match your skills and work experience.

languagematters is a multi-discipline, multilingual recruitment agency offering a wide range of bilingual jobs in London, the South-east, nationwide and overseas. Our goal is to be the most valued, knowledgeable and indispensable recruitment partner in the language recruitment field.

We work constantly to provide equal opportunities for all, regardless of age, gender, ethnicity, social background, religion, disability or sexuality.

NB: Candidates must be eligible to work in the UK or hold a valid work permit. Please note that we contact successful candidates within 3-4 working days. languagematters is acting as an employment business in relation to this vacancy.