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Quality Assistant
OximioTörökbálint, PE, hu1 napja
Állás típusa
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Munkaköri leírásWithin the scope of competence, limited by the position of this job description, be able to sign and verify documents. Have a direct line of communication with and be part of management. Have access to all areas and records which relate to Quality Group activities being performed. Internal contact at all levels within the Oximio group. Utilization of company equipment and computer systems. Ability to interact at high-level with Clients, Vendors and Suppliers. Participate in the discussion of issues related to the performance of duties. Within competence limits, inform management of deficiencies encountered in conducting duties and make proposals for improvement. Submit competent and substantiated proposals for improving working conditions and other rational proposals for consideration to Direct Manager. To request personally or on behalf of the Company's Management from Departmental Managers or other employees’ information and documents needed for the performance of official duties. Higher education Relevant, demonstratable experience in a similar level role Knowledge and experience in global, multi-site, multi-cultural organisation Excellent national and international QA systems experience QA experience at least three years (preferably in pharmaceutical logistics) Familiar with quality standards and processes Good knowledge of Microsoft Excel, Word, and Power Point applications Strong numeracy skills Has self–awareness and cares about the impact they may have on others Fluent in English language written and verbal Exceptional attention to detail that delivers quality information Excellent, caring, and honest communication skills and able to influence Executive level colleagues Coaching and development skills Ability to deliver on commitments Reliable, punctual, and organised Logical and methodical and exceptional attention to detail Approachable and able to effectively build honest relationships with a diverse range of people, handling employee matters with the utmost care Ability to think innovatively to problem solving Ability to effectively adapt to change to deliver a quality service Able to embrace and live the Oximio vision and values Being inquisitive and innovative in increasing knowledge, developing skills and abilities Effectively communicates with all colleagues, clients, and suppliers, professionally, honestly, and timely, gaining feedback from colleagues and peers to achieve personal growth and improve effectiveness and peers to achieve personal growth and improve effectiveness.
Job Description
The Quality Assistant is the local and global support for all quality matters including implementation of quality procedures, standards and specifications across all activity, auditing to ensure compliance and making sure corrective actions are taken to minimise future occurrences.
Responsibilities
- Implementing global Quality Assurance strategy locally that outlines goals for activities such as building effective Quality Assurance procedures, audit standards and ensuring consistent application, making sure appropriate corrective actions are carried out to minimise future occurrences.
- Implement local P, SOP, WI, SF and other documentation that provides guidance and clarity on procedures concerning clinical trials logistics.
- Ensure that all operations are performed according to the applicable standard procedures and working instructions in the Hungary Warehouse.
- Ensure improvement of effective Quality systems and procedures locally.
- Participate in review of local and global Standard Operating Procedures, Work Instructions, Standard Forms, and other documents.
- Maintain Quality Management System documentation in electronic and paper form.
- Informing Hungary personnel about new documents issue / documents update.
- Conduct Quality Management System trainings : procedures, GxP trainings, onboarding trainings locally .
- Lead Client’s external audits, providing documentation required during external audits and assessment, providing response concerning observations occurred during external audit.
- Ensure that all operations are performed according to the applicable standard procedures, working instructions, ISO 9001, GxP requirements, local and global legislation requirements.
- Prepare Suppliers audit schedules and assist in audits of Suppliers, preparation of audit report and control of Corrective and Preventive Actions implementation.
- Participate in Management Review process, preparing reports on functioning of QMS processes and its effectiveness for Hungary Warehouse.
- Assist and participate in non-conformities investigations.
- Prepare internal audit schedules, conduct internal audits and preparation of internal audit reports.
- Control of timely closure of Corrective and Preventive Actions .
- Ensure timely completion of trainings assigned to Quality Officer.
Authority
Requirements
Qualification
Experience
Skills, Knowledge, and Special Qualities
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Quality • Törökbálint, PE, hu