Always Inspection Readiness Quality Manager
Michael Page
Emilia Romagna, Bologna,
4 gg fa

Our client is an important multinational company operating in the chemical sector. Dettagli sul cliente Our client is an important multinational company operating in the chemical sector.

Descrizione Your 'day to day' As Always Inspection Readiness Quality Manager, you will be part of Global Quality Compliance department and will be reporting to the Manager AIR Quality Compliance.

The position will be based near Bologna. In this role you will oversee, control and coach adherence to Quality Management System (QMS) to increase inspection readiness, compliance and drive elevation of maturity level.

Assess and assist critical stakeholders in quality compliance aspects A key responsibility will be lead review of NC / CAPA / Changes, ensuring quality of records, effectiveness of action planned and timely reporting of KPI and documents.

Additionally, you will oversee delivery of action plan, response plan and training. Finally, you will advocate, promote and transfer know-how and coach on guiding principle on inspection readiness and quality compliance.

  • More specifically, you will : Inspection Readiness Model deployment execution in different locations / sites o Review of critical quality records, perform compliance checks (NC / CR / Audit Findings / Complaints / Recall) & Provide guidance on NC, Change, CAPA and Exception Management o Verify and ensure quality of records, effectiveness of remediation o Verify Review of documentation to be sent to Regulatory Bodies (Submission of full Package / Annual Report / Inspection Response / and related correspondence);
  • o Support interaction with regulatory authorities to ensure successful regulatory inspection; o Support strategy for effective QMS deployment and for building PMI quality culture and capabilities;
  • o Identify applicability of findings for other company entities; o Coordinate reporting and follow-up on open NC / CAPA / changes o Ensure execution of selected escalated NC / CAPA / changes Drive increase of Inspection Readiness Maturity Level for selected entities and identify need of the transfer of know-how and knowledge accordingly o Define Role & Responsibility o Identify SME, define knowledge gap and coach o Collect and verify checklist for inspections.

    o Drive planning and execution of response to audits findings Various support to AIR Quality compliance Manager o Advise on critical points of attention o Authoring SOP and wiki o Participate to risk assessment and definition of Maturity level o Propose and implement process improvement (incl.

    systems) o Prepare process description and training Profilo del Candidato Who we are looking for : University degree in Engineering, Chemistry or related field Substantial experience in Quality Assurance in API industries, pharmaceutical industries or medical device industries and GXP controlled environment Profound knowledge in FDA, US GXP and EU regulations relevant for audit / inspections, qualification / validation, compliance systems Excellent communication, project management and decision making skills Proficient in providing solutions for complex challenges Ability to work independently in a team environment Past experience in working within a cross-functional, multidisciplinary and project team oriented environment to ensure project and business alignment Fluent in English, both written and spoken.

    offerta di lavoro Great opportunity

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