Commercial Quality Specialist, GDP RP SK
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- Veröffentlichungsdatum:
- Enddatum:
- ID:
- 2607046438W
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Was wir tun
Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.
Wer wir sind
Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.
Rollenberichte an:
Manager Commercial Quality BENALP (interim SVK, CZ, HU)Standort:
Europe/Middle East/Africa, Slovakia, Bratislava, BratislavaArbeitsort:
HybridWas Sie tun werden
Commercial Quality Specialist:
To participate in projects and activities on cluster or regional level
Support in EMEA, CE and CEE CQ projects in order to keep high level of or improve GxP compliance as well as Excellence in Execution
To be the partner for the local business management of the Marketing Company (MC) in all local Quality & Compliance issues and questions
To ensure that all legal requirements are respected, particularly the Cluster and country specific ones applicable for all activities/processes and products in the MC
To ensure that in every business decision and process potential quality and compliance impact is assessed and respected
To deploy locally all applicable Cluster, Regional and/or World-Wide Quality and Compliance Policies, processes, procedures and requirements, ensuring compliance with the JNTL Quality Policy
Approval of Finished Good Specifications in Document Management System
Performance of First Article Inspection (if applicable)
Initiation of non-conformances (INV) and change controls (GCC)
Conduct internal and external audits (supplier, distributor) following the CE audit program and ensure necessary CAPA´s are implemented
Initiation of QA training for new employees
To support management of local co-packing/rework operations in SK/CZ - ensure GMP & GDP compliance for products during customization and transport to / from the co-packer
Communication with stakeholders
To retrieve CoA´s from the system
To maintain Artwork overview for release needs and share with the warehouse and ensure the data are up to date
To supervise non-product related Change Control management in Slovak Republic
Qualified Person SK:
All actions are in accordance with Act No. 362/2011; Decree of MoH 128/2012 and GDP Guidelines.
Communication of (potential) significant quality issues to local Health Authorities in a timely manner and in line with local requirements (for GDP responsible person). Respond to authority enquiries as required by the GDP responsible person role
To record any quality issues related to product and GDP into company INV&CAPA systems and manage the ones related to GDP in Slovakia
To coordinate and perform the administrative release of drug products in the local warehouse/crossdock according to local requirements and SOP
To approve destructions of drug products
To approve re-distribution of returned drug products
To report deliveries and consumptions of drug products to HA according to local requirements
To focus on accuracy and quality of records
To ensure GxP relevant, MC specific suppliers and service providers are selected, qualified, audited and monitored and Quality Agreements are established according to schedule and applicable QSPs and STDs
To regularly attend GDP conferences/trainings or other education programs
To manage all required SOP´s in Slovakia relevant to distribution of JNTL products
To ensure all involved departments and 3PL are trained on relevant SOP´s with every new revision
To ensure that all implemented Quality & Compliance processes/procedures are constantly met through all local operations
To ensure supplier´s and customer´s GDP & Wholesaler license validity
To lead/coordinate any potential recall in Slovak Republic
To handle Escalations and Field Actions
To perform mock-recall
To prepare and lead inspections of the Slovak MC by local HA
To have a regular oversight on local requirements
To have an oversight on complaints from customers
To perform 3PL Inspection once per year and have an oversight on delegated actions
To perform W2W in the warehouse every year
To ensure self-inspection is performed every year
Essential knowledge and skills:
University degree in Pharmaceutics
Knowledge and experience with quality systems
Experience in production, Quality or RA or medicinal products, cosmetics, food supplements, medical devices or equivalent
Knowledge and experience in working in GDP and/or GMP environment
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