Novartis zoekt een

QA Documentation Coordinator (m/f/d)

Baarle-Nassau, Netherlands

About the Role

Location: Holland, Baarlé-Nassau

We are seeking a Quality Assurance Documentation
Coordinator to manage some quality aspects and projects, as well as to ensure and support overall GxP Conformity and Compliance with the Novartis Quality Management Systems.

This role will work directly with the [QA Systems] team and reports to the [QA Systems Manager].

Key Responsibilities:
• Issuance of controlled documents such as batch manufacturing protocols, cleaning records, validation records, etc., as well as assurance that quality systems documents are archived, such as batch protocols, QC records, maintenance, and calibration records, etcetera, this includes (scanning) paper and electronic archiving.
• Act as main point of contact for IDB’s quality systems, documentation system, and guide colleagues in document creation and editing.
• Acts as main SOP Manager and ensures timely issuance of draft documents and the coordination of document upload, as well as approvals and updates.
• Coordinates and monitors Quality Supports Services from Quality Service Center.
• Coordinates the creation of the (re)design and coordinates the execution of the documentation system for the ongoing site expansion project.
• Works in close collaboration with the Training Responsible Person to ensure proper training arrangements are in place prior to documents becoming effective, ensuring that associates comply with (on the job) GxP training requirements. Furthermore, defines, supports and ensures timely implementation of Quality Systems related CAPA’s, Quality Events, Changes.
• Assists during inspections/audit preparation and during inspections.
• Identifies opportunities and drives continuous improvements across quality systems, e.g. digitalization, standardization projects…
• Act as backup for the QA Officer (Operations) and Training Responsible Person.

Diversity & Inclusion / EEO

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

Role Requirements

Essential Requirements:
• Higher professional education level (HBO or Bachelor).
• Knowledge of TQM and related industry GxP standards and processes.
• Knowledge of compliance requirement for all internal and external regulations.
• Expert in Microsoft Word and Adobe.
• Excellent knowledge of English and Dutch, both verbal and written.

Desirable Requirements:
• Preferably a first experience in the pharmaceutical industry (GxP).
• Experience in Document Management System (e.g. Documentum).

What we offer
• Competitive salary, annual bonus, pension scheme, voluntary contribution collective health insurance, 27 days annual leave, paid parental leave, flexible working arrangements, home office allowance, employee recognition scheme, bike scheme.
• A curious, unbossed and inspiring international work environment.
• A chance to help us build the portfolio for the new brand.
• Plenty of chances to work on your personnel development.

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network (link is external)

Information
For more information about the position, please contact the Staffing Center via staffing.centernl@novartis.com .

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