Specialist QA – GMP Quality Systems Compliance

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Leiden, Netherlands

Job Description:

Are you ready to take on a unique and exciting opportunity as a Specialist QA – GMP Quality Systems Compliance? Johnson & Johnson is seeking a highly motivated individual to join our team in Leiden, Netherlands with an unlimited contract.

This is your chance to be part of a world-class organization that is committed to innovation and delivering flawless quality in everything we do.

As the Specialist QA – GMP Quality Systems Compliance, you will play a crucial role in ensuring that our operations meet the highest standards of quality and compliance.

You will have the opportunity to work with a team of exceptional professionals and contribute to the success of our goals.

Ensures a professional, up to date, high quality level of JBV’s core Quality Systems and its application of these systems to maintain and improve the compliance status of JBV’s processes and systems in line with the regulatory, JBV, Janssen Supply Chain and J&J standards.

Develops and updates quality systems and procedures when appropriate.

Advises Q&C Management and the executing departments regarding compliance issues and ensure resolution.

Essential Job Duties and Responsibilities GMP Specialist

Acts as a Center of Expertise for GMP core quality systems.

Maintains and improves GMP core quality systems, ensuring that the JBV quality systems are compliant, state-of-the-art, and efficient.

Ensures consistency in the quality systems across processes and departments.

Has an outstanding knowledge of GMP regulations, Janssen and J&J standards and translates these requirements in JBV systems that are compliant.

Is responsible for the Inspection Readiness program for the quality systems under his/her responsibility ensuring that JBV is in compliance with the GMP regulations and has a high First Time Pass for all regulatory inspections.

Performs internal audits as a (lead/team) auditor.

Identifies critical areas for improvement through audits and assessments and prioritizes and executes the compliance improvements initiatives resulting from this.

Uses appropriate assessment tools (e.g., PE, Lean, Risk Management principles) in assessing the status of current quality processes and in introducing improvements.

Ensures that quality initiatives are implemented effectively across all relevant...