Compliance and Quality Assurance Coordinator
Miejsce pracy: Gdańsk, ul. Marynarki Polskiej 197
Summary of job:
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.Main tasks and responsibilities:
- 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.
Requirements:
- 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.
What we offer:
- 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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