QA Specialist - Systems Training & Documentation

QA Specialist - Systems Training & Documentation

Location: Beerse - Hybrid working 3 days a week on site

Duration: until end of year

Hours: 40 hours per week

Imagine your next project managing and supporting the J&J Quality systems for Document Management System (Truvault/Veevault) and Learning Management System (Summit) with J&J Innovative Medicine.

QA Specialist will perform standardized tasks in accordance with official procedures and processes. The focus is on managing and support of the J&J Quality systems for Document Management System (Truvault/Veevault) and Learning Management System (Summit). This role offers general Quality Systems support. Can act as Superuser for TruVault, Summit and other relevant J&J Quality systems.

roles and responsibilities.

Documentation Management:

• Responsible for the effective administration and coordination of controlled documents within DPDS Beerse, including:

• Providing administrative support for the controlled document lifecycle

• Preparing monthly backup reporting on the periodic review status of procedures for the business

• Acting as Business Administrator in TruVault, requiring in-depth system knowledge and expertise

• Monitoring and following up on required actions in TruVault to prevent delays in Document Routes and ensure timely effectiveness of controlled documents

• Converting procedures into the appropriate template and performing format reviews to ensure compliance with applicable standards

• Initiating Document Routes based on accurate and complete input provided by the business

• Performing the Document Coordinator role in alignment with the relevant department and QA stakeholders

• Creating controlled print copies, where applicable

TruVault Support, Training, and Access Management:

• Serves as a key point of contact for TruVault-related support and user administration, including:

• Providing first-line support and resolving user questions related to TruVault

• Organizing and delivering TruVault training for new users

• Supporting the request and approval process for required user access rights within TruVault

Continuous Improvement:

• Contributes to the ongoing optimization of the TruVault document management system by:

• Identifying, reporting, and escalating system issues and improvement opportunities to the global TruVault helpdesk and other relevant stakeholders

• Reviews as SME documents for compliance with GMP regulations; guidance, company standards and other SOPs for impact on patient safety and product quality

• Acts as SME for internal and external archiving

• Manages issuance and archival of quality records like test records, external reports, logbooks etc. onsite and off-site for long term preservation, and provides content of superseded and obsolete documents upon request

Training Management:

• Maintains the Learning Management System (LMS) in support of the operational departments

• Acts as Business Learning Administrator for the Summit system, requiring in-depth knowledge and understanding of the system’s functionality, including:

• Managing and maintaining employee training files and training records to ensure they remain accurate and up to date

• Monitoring training completion for temporary staff

• Registering GMP training in CEA for contractors

• Acting as Business Administrator for EVAL, including overdue GxP training impact assessments

• Acting as Business Administrator for EMERGE, including job descriptions, training plans, and Summary of Experience documentation

Summit Training System Support:

• Serves as a key point of contact for the Summit training system, including:

• Providing training on the use of Summit

• Supporting requests for the necessary user access rights within Summit

• Resolving and responding to questions from Summit users

• Preparing reports in Summit

Training Continuous Improvement:

• Contributes to the continuous optimization of the Summit training system by:

• Identifying, reporting, and escalating system issues and potential improvement opportunities, including to the global Summit helpdesk

• Supports Department Lead regarding training related responsibilities

GMP Compliance:

• Ensures strict and consistent adherence to all applicable cGMP requirements and procedures

• Promotes a strong culture of quality awareness across the organization

• Reports incidents and deviations in accordance with established procedures

• Contributes to and recommends solutions aimed at strengthening and continuously improving GMP compliance Internal auditing and inspections, Regulatory requirements:

• Assists with preparation and provides support for internal audits, regulatory authority inspections and ERC inspections

how to succeed.

• Must be able to understand, read and write in English

• Bachelor’s degree in a life science study or equivalent experience

• 1-3 years of experience in a pharmaceutical environment

• Good organizational capabilities

• Flexible and accurate

• Preferably familiar with GMP

• Dutch language is appreciated

benefits.

This role offers a very competitive hourly rate. This contract will run for until end of year

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine.

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process.

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.