Informacje o stanowisku
To provide quality support for planning, conducting and documenting all project – related activities in conjunction with Project Managers and assigned Study team (Logistics, Laboratory), ensure their adherence with clinical protocol, Analytical Plan, MICS QMS documentation as well as the contractual agreements.
- Reviewing and performing internal audits or the study specific audits, included by not limited to revision of study specific documents.
- Ensuring local processes quality and compliance control to perform in-process audits when internal issues are identified.
- Collaborating with Affiliate and subcontracted laboratories with regards to changes in laboratory processes, reference values and/or methodology to ensure the availability of supporting records of such changes.
- Supporting in administrating all quality system documentation: SOPs, instruction, forms.
- Participate in preparing and archiving QMS documents.
- Supporting in monitoring all main processes in MICS by performing internal audits, analyzing nonconformities and implementing corrective actions.
- Supporting in performing external audits of third party vendors/affiliate labs/ subcontracted laboratories.
- Solving quality issues and queries from clients.
- Participation in remote or on site audits.
- Bachelor or Master degree in natural science and/or Quality Management education.
- English – intermediate (min. B2).
- Excellent analytical skills and good knowledge of MS Office (Word, Excel and PowerPoint).
- Must possess excellent organizational skills.
- Resistance to stress and ability to work under time pressure.
- Ability to deal with problems involving several concrete variables in standardized situations.
- Details focused with the ability of not losing the big picture, with prioritizing skills.
- Attach CV in English.
- Stable employment based on an employment contract.
- On site.
- Full-time job (Monday – Friday – 8h).
- Flexible working hours (start between 7:00 and 9:00).
- Social benefits package (medical care, sports card, card subsidy, Benefit program).
- We will provide you with a comprehensive introductory training (min. 1 month) followed by the support of a mentor (Buddy).
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