Junior Specialist Quality Europe Lazio

Junior Specialist Quality Europe
Roma
Lazio, Lazio

1.

Primary Objective of Position

- Supports Quality System compliance in a specific region or regions.

- Supports a specific process or processes for the whole Europe/EEMEAP as Subject Matter Expert (SME), its backup, or part of the team

2.

Major Accountabilities All Specialists:

- Supports the Manager QA Region to ensure Europe/ EEMEAP and Region Quality System effectiveness and compliance:

- Performs internal and supplier audits.

- Supports / prepares/ coordinates external audits.

- Review & approve locally developed AdPromo material in local language on behalf of Regulatory Affairs

- Supports the Europe/ EEMEAP common Quality System and QS processes: e. g.

Field communications, supplier evaluation, audits and CAPA, AdPromo, document control and record keeping.

- Is responsible for specific processes as SME backup or team member o Review Abbott policies & procedures, and update Quality documentation accordingly.

o Manage any audit input by initiating changes to affected processes following MIMS change control procedures.

Participates in Quality System improvements and implementation projects Specialist/ Senior Specialist only:

- As MIMS lead SME, is responsible for specific Quality System processes and is procedure owner.

Leads process improvement projects and transition to new procedures and requirements

- Supports commercial organization in contracts and public tenders (QARA, EHS requirements) in collaboration with the QA team SME, RA and EHS Senior Specialist only:

- As the most experienced Quality Specialist: o is the backup for the Manager Quality in the Region o is the preferred MIMS lead or backup among the quality specialists

3.

Education

- Scientific background (i. e.

Lab Technician, Biology, Chemistry, Pharma, M. D. , Engineer) preferred.

Other education is acceptable if experience of 2 or more years in similar position or in medical device industry in a related position.

4.

Background

- Specialists can have experience in one or several of the following: o Quality Assurance in a commercial affiliate at the diagnostic/ medical device/ pharmaceutical industry is preferred.

o Regulatory Affairs, Customer Service or any other commercial affiliate function at the diagnostic/ medical device/ pharmaceutical industry, o Manufacturing/ Distribution/ Clinical laboratory/ Competent Authority/ IVD/ MD