![Abbott Laboratories](https://media.trabajo.org/img/noimg.jpg)
Junior Specialist Quality Europe
6 giorni fa
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
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