GMP and Compliance Specialist

Job description

"Caring for the world... one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo .

Janssen Vaccines AG , one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide.

The Bern site acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and is recently expanding its portfolio into bacterial based therapeutic products

For our site in Berne we are looking for a highly committed

GMP and Compliance Specialist

Your main tasks will be:
· Responsible for the GMP readiness concept and compliance in the R&D organization
· Primary point of contact for quality and GMP tasks and issues within the R&D organization and interface to local R&D quality
· Coordinates and tracks quality/compliance relevant metrics and trending data and presents data to shop floor people.
· Maintains a quality compliance awareness/commitment of the shop floor people (GMP discussion, workshops, etc.)
· Responsibility for local implementation of quality standards and procedures
· Developing and implementing improvement programs and assisting the training department and training coordinators in definition and roll-out of tailored class-room and individual trainings
· Providing Key User support in the application of quality relevant IT systems (Trackwise, Compliance Wire)
· Change control owner and coordinator for all the R&D organization related Change Controls
· Establishing and maintaining inspection and audit readiness for the R&D organization
· Supporting R&D organization in audits, close-out of audit findings, root cause investigations, non-conformances, CAPAs and change controls
· Maintaining GxP action and self-auditing plans and tracking of quality metrics

Desired profile

Qualifications :

·  Bachelor/Master degree in Natural or Technical sciences or equivalent
·  A minimum of 3 years' experience within the Pharma or the Biotech Industry
·  Good GxP knowledge with at least 3 years' experience in a GMP environment
·  Know-how of quality assurance principles (cGMP)
·  Know-how of manufacturing quality principles (cGMP)
·  Know how about biological manufacturing processes
·  Experience in inspection of regulatory agencies
·  Analytical thinking and problem-solving ability
·  Business fluency in German and English is a must
·  Furthermore, we are looking for a flexible team player, self-starter, multitasker and a good time manager

We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms. Have we piqued your interest? Please send us your online application (CV, Working References etc.).

Check our career channel on YouTube www.youtube.com/user/CareersAtJNJ to understand our working culture!