GMP Scientific officer

The role is for a Scientific Officer in the Inspections Office, Quality and Safety Department of EMA’s Human Medicines Division.
The scientific officer is expected to provide scientific, regulatory or procedural input relating to Good Manufacturing Practices (GMP) Inspections and market surveillance activities for human and veterinary medicines.
The scientific officer may support the implementation of the future revised Pharma Legislation in the area of inspections, including the potential set up of an Agency inspectorate.
In this role you will be supporting oversight of global pharmaceutical manufacturing via inspection co-ordination, providing inspection input during marketing authorisation assessment, and supporting the management of quality defects and recalls. You will also have the opportunity to work with highly qualified experts across the EEA and globally (e.g. US-FDA, JP-PMDA and WHO), via support at Good Manufacturing and Distribution Practice (GMDP) Inspector Working Group meetings. Such activities include a particular focus on developing harmonised guidelines, for example in innovative areas of manufacturing, and ensure best use of resources to strengthen oversight of manufacturing via reliance initiatives.

In this role you may also support with implementing changes and new requirements for EMA as mandated by the expected future revision to the Pharmaceutical Legislation, a considerable opportunity for the strengthened protection of public health. This could include, but not limited to, support setting up a quality management system for a potential new EMA inspectorate, developing scientific guidelines and procedures in the area of GMP Inspections in collaboration with the GMDP Inspectors Working Group. It could also include the development and coordination of a 3rd country inspection programme in close collaboration with Supervisory Authorities across the Network.

As GMP Scientific Officer in close collaboration with the various functions across the EMA, you will cover one or more of the following areas:

• Provide scientific specialist expertise, coordination and regulatory support to the review of manufacturing aspects for human and veterinary medicines and their supply chains across the life-cycle of the medicinal product (e.g. scientific advice, evaluation of marketing authorisations and post-authorisation variations and line extensions, quality defect procedures).
• Coordinate supervision of compliance with Good Manufacturing Practices (GMP) and market surveillance activities for human and veterinary medicines throughout their lifecycle.
• Provide scientific and regulatory support on GMP compliance matters to the GMDP Inspectors Working Group and provide training as required.
• Support the development of regulatory and scientific guidance documents by coordinating preparation with EU Network experts and providing technical and regulatory input to ensure consistency with the applicable EU pharmaceutical legislation and regulatory requirements.
• Collaborate with international partner authorities in the harmonisation of manufacturing or inspection standards and practices.
• Provide regulatory support to requests for information from external stakeholders.
• 3rd country Inspection programme coordination.

Please note that there are two types of vacancies arising, support of core activities, and the support of the new pharma legislation. Both roles will require travel, however, the role supporting the new pharma legislation may require extensive travel.

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Here is the link to the Role Description of Scientific Officer outlining generic duties and responsibilities: https://www.ema.europa.eu/en/documents/recruitment/role-description-scientific-officer-fgiv_en.pdf

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:

General conditions:
1. You enjoy full rights as a citizen of a European Union Member State or Iceland, Liechtenstein and Norway;
2. You have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3. You have fulfilled any obligations imposed by applicable laws concerning military service.

Specific condition:
You possess a university degree of at least 3 years in Pharmacy, Engineering, Chemistry, Biochemistry or other relevant life-science degree that must have been obtained by the closing date of this vacancy notice.

General Condition 1 and Specific Condition will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.

Only candidates eligible will be assessed by the Selection Committee.

At least 2 years of relevant experience in either a competent authority in the field of medicines assessment or inspections or the pharmaceutical industry obtained in the scientific, regulatory, or procedural aspects of the research, development, authorisation, production or supervision which includes experience in:

OR

Grade competencies

Core competencies

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.