Deviations Lead

Location: Leiden 

Duration: 12 months contract

Hours: 40-32h

Hybrid way of working

Imagine your next role as a Deviations Lead who is a GMP specialist and is responsible for leading the deviation investigations of any deviation that occurs in the clinical manufacturing facility. 

About the department and the role 

The operations department plays a central role within BU3 clinical manufacturing team and is responsible for on-time manufacturing and delivery of the planned NPI and Resupply within the year. High quality is a ground rule for delivering a safe product to the patient.

The GMP & Compliance team is responsible for the general GMP & Compliance-related items for the clinical area and supports the production team with specialized and in-depth knowledge and skills on the GMP processes and systems (Quality Investigations, Continuous GMP improvements, training creation, etc…)

The GMP team is looking for a motivated and high skills team member who would like to support the production team with KPIs, in particular Non-conformances, CPAs, and corrections.

About the Deviations Lead role 

As a Deviations Lead you will be responsible for leading the deviation investigations of any deviation that occurs in the clinical manufacturing facility. You will be responsible for opening and closing the loop while investigating, including Product Impact Assessments, Root Cause Analysis, and Corrective Actions. You are responsible to follow up on the RCA (root cause analysis) and making sure that the progress is documented in a compliant way. Additionally, you will also work on the maintenance and improvement of general GMP processes, if needed. Examples are supported in emergency Change Controls, Training, updating general GMP procedures, support in inspections, etc.

You collaborate closely with the operations department, the equipment owners and the process engineers, and other staff members of the API CM department. Also, you are a key contact for and work closely with the Quality Department.

Responsibilities

⦁ Lead deviation investigations and documenting product impact analysis and root cause investigation, including CAPA records

⦁ Develop adequate measures to show the effectiveness of the corrections and CPAs.

⦁ Develop/implement the tools needed to ensure that deviations are executed in a compliant cGMP manner.

⦁ Responsible for follow-up, and ensuring compliant documentation and timely completion;

⦁ Ensuring that relevant corrections and/or improvements on production processes and systems are made within the API CM team;

⦁ Monitoring progress and KPI for this process

⦁ Support in keeping general API CM GMP documentation up-to-date;

⦁ Training coordination and responsible for the training syllabi within the API CM department;

⦁ Support of documentation periodic review within the API CM department;

⦁ Support internal batch release process.

⦁ Compliance with the GMP, EHS, and SOX requirements and guidelines, which are connected to the respective function\

⦁ Represent Operations on cross-functional project teams

⦁ Facilitate an environment of continuous improvement & open communication 

⦁ Lead investigations in the work area as necessary 

⦁ Lead Cross-Functional teams as necessary to support site goals.

⦁ Demonstrate the Credo value of integrity.

how to succeed

The ideal candidate will have:

• A relevant third-level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering

• Previous experience as a deviation lead in a cGMP environment is required

• Manufacturing experience within a GMP-regulated environment.

• Relevant work experience in a biotechnology or biopharmaceutical industry environment. Technical background (TU) is also okay.

• Familiarity with learning management, tracking systems, and Trackwise QEM

• Analytical ability and ability to deal with complexity

• Good communication in English, both ver ally and in writing.

• A high degree of accuracy, initiative, and independence.

• A personality who is positive, hands-on, flexible, stress-resistant, innovative, and proactive 

benefits

This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for 12 months.

you are welcome here

Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.

about Janssen Biologics

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/netherlands/nl

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. 

questions

If you would like some additional information about the role please contact:  katerina.alikaridou@randstadsourceright.nl

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”.