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Data : 24-nov-2020
Luogo : Poggio Rusco, 25, IT, 46025
Società : Steris Corporation
Principal Duties and Responsibilities :
To review batch documentation after processing and to ensure that errors problems and anomalies are fully investigated and documented.
To be responsible for product release for all processes at site.
To ensure Quality System in Production is in compliance with STERIS Procedures, Standards and any Applicable Laws.
To initiate, investigate, control and analyse non-conformance reports in collaboration with Site QA Supervisor, ensuring all relevant parties are informed and where appropriate, to ensure corrective action, in collaboration with all departments involved, is implemented and that it is effective
To initiate, investigate, control and analyse the recording and investigating of Customer complaints in collaboration with Site QA Supervisor.
Where justified Customer complaints, to ensure corrective action, in collaboration with all departments involved, is implemented and that it is effective
To support the Site QA Supervisor, in conjunction with the technical groups, to verify the conformity of all process validation documents (PQ) and in collaboration with Validation Department and the Site QA Supervisor, to ensure the need for validation is identified and ensuring that the appropriate action is taken.
To support the Site QA Supervisor in Quality and GMP training of all site personnel. To develop, support and maintain the Production Employee Training Program about Quality Guidelines.
To identify and report any failures in the implementation of the quality system to the Site QA Supervisor and Operations Management.
To investigate such matters and recommend appropriate corrective action, in collaboration with the Site QA Supervisor.
To support and facilitate Audits (Regulatory Inspections, Audits by Customers, audit to Supplier) in collaboration with the Site QA Supervisor.
Ensure that the internal audit program is executed as per plan and perform audits as required in collaboration with the Site QA Supervisor
Ensure that the internal and external calibration schedule is executed for applicable instrumentation, in collaboration with the Site QA Supervisor
To support the Site QA Supervisor to manage and formalise all process changes.
monitor day to day CAPA reporting to ensure timely closure.
To support Site QA Supervisor to ensure that plant re-qualification / verification is executed as per Quality Management System requirements.
To support the Site QA Supervisor to implement, monitor and report on Customer service related corrective actions as required.
To support the Site QA Supervisor to review each Quality Agreement with the Customers.
To work in close co-ordination with the Site Manager (Production) and Customer Support.
To inform immediately the Site QA Supervisor and the Country Quality Manager ITA in case of critical issues.
To support the Site QA Supervisor and the Country Quality Manager ITA to Implement continuous improvement activities in agreement with the Operation Manager.
to assist the Site QA Supervisor and the Country Quality Manager ITA in the application of the management of QMS in Production.
provide professionalism and courtesy at high level; attend any meeting with the Customers supporting the Site QA Supervisor and the Country QA Manager.
Position SummaryDutiesDuties - cont'dEducation DegreeRequired ExperiencePreferred ExperienceSkills
MINIMUM REQUIREMENTS AND SKILLS
degree in a science (pharmacy, CTF, biology, biotechnology, Biomedical engineering, chemistry)
minimum 1 year of experience in Production / QA activities in Healthcare Industry
preferable and appreciable knowledge in ISO 13485, GMP and quality management
good level of English reading, writing and speaking communication skills
drive license minimum B level
full availability to travel
Team work attitude
knowledge in Microsoft Office applications (Word, Excel, Access and Power Point).
Part time 20 hours weekly working time in case of needs, the person should be flexible and support general improvement of the Company through Quality related activities
Maintain good relationships with the Production and QA team, co-workers and all departments.
Autonomy, accountability, proactive, focus on the goals, in agreement with STERIS values, Quality and Safety Policies.
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