Global Quality System

vor 1 Monat

Ludwigshafen am Rhein, Deutschland ABBVIE Vollzeit

Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You’ve found the right place
As part of our Documentation team, you will act as primary interface between the GQS Documentation Function and supported R&D business units inclusive of Operations Documentation function. Act as the Subject Matter Expert for Quality Documentation process and standards at the site level

Further develop your expertise and join our team as **Global QualitySystem Site Documentation Lead** **(all genders)** (permanent/fulltime)**

This means:

- Act as SME and Documentation function lead within R&D Site for quality and compliance aspect in respect to
Documentation Standards related to Quality System documentation inclusive of providing consultation and support for site related initiatives.
- Work on and lead special quality projects as assigned by Quality Management. Provide both training and assistance to site functions for documentation standards and document change controls when handling GxP documentation and product documents.
- Lead site documentation teams focused on initiatives associated with general documentation standards, quality knowledge management and Quality System / Product Documentation improvements
- Provides input into overall team strategy and framework development for new and emerging initiatives (incl. mid
- and long term team goals).
- Decision making skills - discern information and analyze how different factors can affect business operations and ability to evaluate different perspective or approach
- Manages and leads global compliance and continuous improvement projects related to Quality System documentation.
- Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi
- and cross-functional documentation review and approval.
- Develops strategy for creation of complex QS procedural documents involving cross-functional teams.
- Drives continuous improvement of Quality Documentation Standards
- Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.
- Provides training and assistance to R&D colleagues for documentation standards and documentation change control process when handling GxP documentation.
- Provides support during audits and inspections.
- Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM)
- Maintains notifications, relations, and other property information within the Document Management System (DMS).
- Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.
- Supports and coordinates of document translation process (incl. Translation checking (Ludwigshafen only) as applicable.
- Collects and reports documentation-related key performance indicator metrics.
- Provides input into overall team strategy and framework development for new and emerging initiatives (incl. mid
- and long term team goals).

This is how you can make a difference:

- Bachelor's degree (technical/scientific area preferred) or equivalent experience.
- Minimum 6+ years of pharmaceutical experience in a GMP environment administering Document Control System
- 5-6 years' experience using and administrating electronic document management tools
- Minimum of 2 years' experience in a leadership / team lead role
- Advanced understanding and knowledge of GxP requirements and pharmaceutical regulations
- Reliable and independent work style, excellent organizational skills, attention to detail
- Advanced oral and written communication and teamwork skills
- Advanced knowledge and experience with Microsoft Office products
- Advanced analytical thinking and comprehension; data processing skills
- Fluent in German, excellent spoken and written English skills
- Knowledgeable in the end-to-end sample lifecycle
- Proficient with applicable LIMS software
- Leader and key contributor to initiatives and advancement of LSO as an organization

What we offer you:

- a diverse area of work where you can make a real difference
- an open company culture
- attractive remuneration
- intensive onboarding by a mentor
- flexible work models for a healthy work-life balance
- corporate health management with comprehensive health and exercise programs
- corporate social benefits
- diverse career options in an international organization
- high-level, attractive career development opportunities
- a stro

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