Job QA Manager in External Supply Operations (ESO)/QP (m/f) Traunviertel siehe Beschreibung - Jobangebote

Berufsbezeichnung:
QA Manager in External Supply Operations (ESO)/QP (m/f)

Arbeitsbeschreibung:
Remarkable developments occur at Sandoz due to the combination of individual characteristics, personal interests and professional qualification. This is why we are seeking employees with a passion for all that they do and who will work together with us to achieve the common goal: to provide patients in Austria and all over the world with high-quality, affordable pharmaceutical products. We, Sandoz, are one of the largest pharmaceuticasl companies in Austria with over 4.000 employees at four sites. As a member of the global Novratis Group, we develop, produce and market generic pharmaceuticals - above all antibotics, injectable cancer drugs and innovative biosimilars. Come and work with us as.... 1 QA Manager in External Supply Operations (ESO)/QP (m/f)

Area of Responsibility

* Ensure GMP-compliance of our contract manufacturing sites

* Maintain and further improve the GMP status in ESO Quality

* Support introduction and ensure compliance with Novartis GMP Quality Manual and GOPs.

* Provide and ensure QA Oversight of contractors relevant for Quality-ESO Oncology Injectables

* Define, measure, and report Key Quality Indicators (KQI) and actions

* Ensure Annual Product Reviews (APRs) and Product Quality Reviews (PQRs) for all relevant outsourced products are received from relevant contractors, that the reports are reviewed, translated in the local system, approved and derived actions are tracked.

* Participate in Supplier Relationship Meetings and visit relevant contractors or stakeholders

* Assesse the risk profiles of relevant contractors (Contractor Quality Risk Assessments - CQRA) in collaboration with other relevant sites and with the local ESO team (MS&T, Purchasing, Supply Chain)

* Plan / support / perform audits and ensure overview of audit status

* Coordinate and update CAPAs and prepare responses for audit and inspection reports

* Supports contractor's management activities to address significant quality issues

* Acts as subject matter expert if needed (e.g. remediation activities)

Qualifications

* Degree in chemistry, pharmacy or other relevant subject

* Certificate as a Qualified person

* Fluency in German and English (C1)

* Curiosity for quality management (production and quality)

* Experience with Audits (authorities, customers)

* Negotiation and communications skills

* Detailed knowledge of relevant GMP; ability to analyze and evaluate GMP compliance

* Good organizational skills

* Willigness to tavel (up to 25%)

Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. modern company pension, training possibilities and global career opportunities).

In accordance with the Austrian collective labour agreement, we have to advise you that the minimum gross annual salary for this role is 55000 euros.

Please apply online under the following link: Online Application

www.sandoz.com/career/career opportunities/Job ID 180912BR

Contact: Karin Stichlberger HR Manager Tel.: +43 7665 8123 108

Das Mindestentgelt für die Stelle als QA Manager in External Supply Operations (ESO)/QP (m/f) beträgt 55.000,00 EUR brutto pro Jahr auf Basis Vollzeitbeschäftigung. Bereitschaft zur Überzahlung.

Stunden pro Woche: 38,50

Angestelltenname: siehe Beschreibung

Arbeitgeber-Adresse: Unterach am Attersee

Form von Kontakt: Frau Karin Stichlberger

Arbeitgeber Telefonnummer: +43 7665 8123-115

Stellenkurzbeschreibung: Apotheker

Land: Österreich

Region: Traunviertel

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Uni/HS

Erfahrung: Gefordert

Quelle des Stellenangebots:
AMS, Öffentliche Arbeitsverwaltungen, Österreich

Fahrerlaubnis: Pkw bis 8 Personen; Lkw unter 3,5 t

Wie Sie sich bewerben: Bewerbung + Lebenslauf an den Arbeitgeber