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Deviations Lead

Deviations Lead GMP specialist

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for a Deviations Lead.

Keywords
  • BSc. or MSc.
  • Deviation lead
  • cGMP
  • Trackwise

As a Deviations Lead, you will be responsible for leading the deviation investigations of any deviation that occurs in the manufacturing facility. You will be responsible for the closed loop approach to investigations, including Product Impact Assessments, Root Cause Analysis, and Corrective Actions. You are responsible that progress is documented in a compliant way. Additionally, you will also work on maintenance and improvement of general GMP processes, as needed. Examples are support 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 VF. Also, you are a key contact for and work closely with the Quality Department.
Tasks and Responsibilities:
  • Lead deviation investigation in documenting product impact analysis and root cause investigation, including CAPA records
  • 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 VF;
  • Monitor progress and KPI for this process''
  • Act as a Subject Matter Expert on Deviations during inspections and audits
  • Inspection readiness;
  • Support in keeping general VF GMP documentation up-to-date;
  • Training coordination and responsible for the training syllabi within the VF;
  • Support of documentation periodic review within the VF;
  • support internal batch release process;
  • Leading process excellence activities to continuously improve the work as well as personal skills.

Profile

We would love to hear from you, if you have a BSc. or MSc. degree in biotechnology, biochemistry, biomedicine, process technology and at least 2-5 years relevant work experience in a biotechnology or biopharmaceutical industry environment. Previous experience as a deviation lead in a cGMP environment is required. Experience with Trackwise QEM is preferred. As a person, you are flexible as you can deal with changing priorities, you are stress-resistant and have a high degree of accuracy.

Benefits

Project for 6 months
Days of leave: 36
See here our other employment terms for this vacancy

Company profile

Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

Janssen Vaccine Facility (VF), part of the Johnson & Johnson Companies, is a state-of-the-art vaccine manufacturing facility at the Bioscience park in Leiden, where they produce leading medicines against diseases that have a global impact, such as vaccines against HIV and RSV. The vaccine facility is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial production. The GMP Department consists of approx. 22 persons who play a central role within the VF to ensure GMP compliance in support of production, product transfers and improvement projects.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Leiden
Deviations Lead

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