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QA Analyst

Data: 21-nov-2020

Luogo: Calcinate, BG, IT, 24050

Società: Steris Corporation

Quality Analist - term contract, 12 months.

 

Principal Duties and Responsibilities:

 

  1.  

To Support all Production Sites in Italy (Calcinate/Seriate/Poggio Rusco) and the QA team in each Site; to support the Country Quality Manager ITA to coordinate all QA team.

  1.  

To back-up, in case of need or urgency, each Site QA Manager/Supervisor/Technician.

  1.  

To support the QA Team and the Country Quality Manager ITA during Audits (Regulatory Inspections, Audits by Customers, audit to Supplier). To ensure that the internal audit program is executed as per plan and perform audits as required, to check results and verified activities proposed and approved as CAPA.

  1.  

In conjunction with the Quality Team, via the formalised change management process, ensure all new equipment and quality related software are qualified and requalified either periodically or after modification prior to use. To undertake projects as and when required in collaboration with Country Quality Manager ITA and Operation Manager and adhere to formalised change management processes.

  1.  

To support the Country Quality Manager ITA to implement continuous improvement activities in agreement with Operation Manager and STERIS policy.

  1.  

To collect all data of Production and Quality performance from each Site Quality Manager/Supervisor/ periodically, elaborate them, develop appropriate statistics and provide a report to Country Quality Manager ITA on a regularly scheduled basis (weekly, monthly and quarterly).

  1.  

To support the Country Quality Manager ITA to prepare, elaborate and draft all data for Management Review Report.

  1.  

To ensure Quality System in each Site and Department is in compliance with STERIS procedures, Standards and any applicable laws and to cooperate with each Site for the successful management of quality issues as directed by the Country Quality Manager ITA.

  1.  

To organize and to be responsible for the Quality and GMP training of all personnel. To develop, support and maintain the Training Program about Quality Guidelines in collaboration with Country Quality Manager ITA. To identify training needs of Quality Team and support them to train each Site about quality matters. To check the status of training plan developed in each Site from the QA colleagues.

  1.  

To support QA Team to draft and manage each Quality Agreement with the Customers, also in collaboration with Country Quality Manager ITA.

  1.  

To support QA Team to manage and control all suppliers, following STERIS and policy requirements.

  1.  

To provide and maintain service excellence to Customers; provide professionalism and courtesy at high level; attend any meeting with the Customers.

  1.  

To undertake any other such duties as may become necessary, and as may reasonably be expected, in the provision of the quality assured service, in collaboration with Country Quality Manager ITA.

Position Summary

QA Analyst - Fixed Term Contract 12 months - Based in Calcinate (BG)

Duties
  • To Support Production Sites in Italy (Calcinate/Seriate/Poggio Rusco) and the QA team in each Site; to support the Country Quality Manager ITA to coordinate all QA team.
  • To back-up, in case of need or urgency, each Site QA Manager/Supervisor/Technician
  • To support the QA Team and the Country Quality Manager ITA during Audits (Regulatory Inspections, Audits by Customers, audit to Supplier). To ensure that the internal audit program is executed as per plan and perform audits as required, to check results and verified activities proposed and approved as CAPA.
  • In conjunction with the Quality Team, via the formalised change management process, ensure all new equipment and quality related software are qualified and requalified either periodically or after modification prior to use. To undertake projects as and when required in collaboration with Country Quality Manager ITA and Operation Manager and adhere to formalised change management processes.
  • To support the Country Quality Manager ITA to implement continuous improvement activities in agreement with Operation Manager and STERIS policy.
  • To collect all data of Production and Quality performance from each Site Quality Manager/Supervisor/ periodically, elaborate them, develop appropriate statistics and provide a report to Country Quality Manager ITA on a regularly scheduled basis (weekly, monthly and quarterly).
  • To support the Country Quality Manager ITA to prepare, elaborate and draft all data for Management Review Report.
  • To ensure Quality System in each Site and Department is in compliance with STERIS procedures, Standards and any applicable laws and to cooperate with each Site for the successful management of quality issues as directed by the Country Quality Manager ITA.
  • To organize and to be responsible for the Quality and GMP training of all personnel. To develop, support and maintain the Training Program about Quality Guidelines in collaboration with Country Quality Manager ITA. To identify training needs of Quality Team and support them to train each Site about quality matters. To check the status of training plan developed in each Site from the QA colleagues
  • To support QA Team to draft and manage each Quality Agreement with the Customers, also in collaboration with Country Quality Manager ITA.
  • To support QA Team to manage and control all suppliers, following STERIS and policy requirements.
  • To undertake any other such duties as may become necessary, and as may reasonably be expected, in the provision of the quality assured service, in collaboration with Country Quality Manager ITA.
Duties - cont'd
Education Degree
    Required Experience

    degree in a science (pharmacy, CTF, biology, biotechnology, Biomedical engineering, chemistry)

    minimum 2/3 years of experience in Quality Assurance (also linked to Production) in Healthcare Industry

    high level of English reading, writing and speaking communication skills

    Team work attitude

    knowledge in Microsoft Office applications (Word, Excel, Access and Power Point).

     

    Preferred Experience

    preferable and appreciable knowledge in ISO 13485, ISO 17025, GMP and quality management

    Skills

     

    MINIMUM REQUIREMENTS AND SKILLS

     

    1.  

    degree in a science (pharmacy, CTF, biology, biotechnology, Biomedical engineering, chemistry)

    1.  

    minimum 2/3 years of experience in Quality Assurance (also linked to Production) in Healthcare Industry

    1.  

    preferable and appreciable knowledge in ISO 13485, ISO 17025, GMP and quality management

    1.  

    high level of English reading, writing and speaking communication skills

    1.  

    drive license minimum B level

    1.  

    full availability to travel

    1.  

    Team work attitude

    1.  

    knowledge in Microsoft Office applications (Word, Excel, Access and Power Point).

    1.  

    full time role; in case of needs, the person should be flexible and support general improvement of the Company through Quality related activities.