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Site QA Manager

Date: 21-Apr-2021

Location: Poggio Rusco, MN, IT, 46025

Company: Steris Corporation

Site Quality Manager - Permanent contract full time - Poggio Rusco (MN)

 

To take responsibility for all quality matters relating to the operations on the site assigned in conjunction with the Country Quality Manager ITA with the following Duties and Responsibilites:

1.            To review batch documentation after processing and to ensure that errors, problems and anomalies are full investigated and documented.

2.            To be responsible for product release for all processing at sites.

3.            To ensure that Quality procedures are current, disciplines are followed and actively promoted and to take responsibility for the successful management of quality issues as directed by  the Country Quality Manager ITA.

4.            To supervise and coordinate the activities carried out by the Site QA Technician and support the Site QA Technician during routine working activities.

5.            To initiate, investigate, control and analyse non-conformance reports 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.

6.            To initiate, investigate, control and analyse the recording and investigating of customer complaints. Where justified customer complaints, to ensure corrective action, in collaboration with all departments involved, is implemented and that it is effective.

7.            In conjunction with the technical groups, verify the conformity of all process validation documents (PQ) and in collaboration with Validation Department, to ensure the need for validation is identified and ensuring that the appropriate action is taken.

8.            To be responsible for the quality and GMP training of all site personnel.

9.            To identify and report any failures in the implementation of the quality system to the Country Quality Manager ITA and Operations Management. To investigate such matters and recommend approriate corrective action.

10.          To manage external audits (from Customers or Regulatory Audits) with or without the Country Quality Manager ITA in attendance. Ensure that the internal audit program is executed as per pIan and perform audits as required.

11.          Ensure that the internal and external calibration schedule is executed for applicable instrumentation.

12.          In conjunction with the Quality Department, 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.

13.          To ensure that plant re-qualification / verification is executed as per Quality Management System requirements.

14.          To implement, monitor and report on customer service-related corrective actions as required.

15.          To undertake projects as and when required and adhere to formalised change management processes.

16.          To work as part of a team responsible for the management of the site in close coordination with Plant Manager s and Customer Support.

17.          To have the authority to stop production, according to Country Quality Manager ITA and STERIS procedures where necessary.

REQUIREMENTS AND SKILLS:

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

2.            minimum 3 years of experience in Production/QA activities in Pharmaceutical/Chemical/Medical Industries.

3.            preferable and appreciable knowledge in ISO 13485, GMP and quality management

4.            high level of English reading , writing and speakin communication skills

5.            drive license minimum B level

6.            full availability to travel

7.            Team work attitude

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

9.            Full time 39 Hours, weekly working time in case of needs, the person should be flexible and support general improvement of the Company through quality related activities.

10.          Maintain good relationships with the Production and QA team, co-workers and all departments.

11.          Autonomy, accountability, proactive, focus on the goals, in agreement with STERIS values, quality and Safe Policies.

The Site Quality Manager is responsible for supervising and coordinating operational activities of the plant assigned, complying with existing standards and quality and safety requirements, maximizing effectively productive capacity, in accordance with customer requirements and agreement