Senior QA Manager/QP #Sandoz [Greece]


 

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!

Together we will shape the future of Sandoz… are you ready to make a difference?

Job Purpose:

The Quality LeadSenior QA Manager/QP for Sandoz Division will work in a positively challenging environment.
He/she will assume the authority and responsibility of releasing finished products to the Greek market as Qualified Person, provide QA support for Greece, Cyprus & Malta and assure compliance with cGMP/GDP legal and regulatory requirements
as well as the Sandoz Quality Manual and Policies.

Key Responsibilities:

1. Assume the authority and responsibility of releasing finished products to the Greek market as Qualified Person, assigned by the Greek Health Authorities.
2. Provide QA Support for Greece, Cyprus & Malta:
  • Drive local implementation of the Quality Manual and Global Operating Procedures .
  • Coordinate third party activities regarding pharmaceutical manufacturing activities (as applicable), such as authenticity labeling (re-) packaging, (re-) labelling, storage and distribution of Sandoz Products, so as to comply with Sandoz and local regulatory requirements.
  • Manage Technical complaints.
  • Act as trusted partner to the business and functions to ensure that we are operating in compliance with local laws & regulations, and internal policies & guidelines.
  • Act as a contact person for the Health Authorities concerning technical and quality issues.
  • Support the vendor quality evaluation process.
  • Support the preparation and maintenance of the Quality Assurance Agreements with third parties, suppliers and/or BD&L Partners.
  • Manage external inspections, complaints, deviations, CAPAs, actions, Recalls, counterfeits and product tampering within area of responsibilities according to the Quality Manual and relevant SOPs.
  • Maintain current knowledge of local legislative requirements and trends necessary for performance of duties through training.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements

Job Requirements:

  • Bachelor's Degree in Science or Engineering
  • 3-5 years in a pharmaceutical manufacturing environment in QA and/or manufacturing roles
  • Qualified Person eligibility is mandatory
  • Languages: Greek and English fluent
  • Good technical understanding of IT systems and should be able to work efficiently with software programs
  • Working experience with SAP is desirable
  • Strong collaborator, networking and stakeholder management, build trust
  • Demonstrate high quality and risk-based thinking, proactive, results driven, solution-oriented approach, organizational agility, priority setting and learning on the fly
  • True interest in understanding complicated product flows and innovative processes, open-minded to new ways of working to identify solutions

Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

#Orbit

Division

SANDOZ

Business Unit

COMMERCIAL OPS EUROPE SZ

Country

Greece

Work Location

Athens

Company/Legal Entity

Nov (Hellas) Greece

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No


 

.

Post a Comment

Previous Post Next Post

Sponsored Ads

نموذج الاتصال