QA qualification engineer (fixed term)
Locations: Beerse, Belgium
Functions: Quality (Eng)
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Requisition ID: 1805703839W
'Caring for the world, one person at a time'... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
The Janssen Beerse Site Quality Department ensures that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of Investigational and Commercial Products at/from the Campus Belgium are carried out as required by GMP legislation.
Within this department, the QA Qualification group is responsible to ensure compliance of all qualification activities for PDMS (Pharmaceutical Development and Material Sciences, more specific for clinical production) and JSC (Janssen Supply Chain, more specific for commercial production).
QA Engineer Lab Equipment Qualification
Reporting to the QA Qualification Manager
You will be employed as QA Engineer related to Lab Equipment Qualification and within this role
* You are responsible for maintaining the qualification status of the lab equipment in the commercial and clinical QC labs.
* You work closely together with the qualification teams for the introduction/retirement of new equipment or changes to existing equipment. You provide advice and support for the preparation of qualification related activities and overview the cGMP aspects in these projects. You are a member of cross-functional teams to realize cross-departmental objectives.
* You approve change controls, deviations and related corrective actions linked with laboratory equipment.
* You maintain a current knowledge of international regulations, guidelines and new evolutions related to qualification topics through training, internal and external benchmarking and literature studies.
* You approve qualification documents such as qualification plans, protocols, reports, master documents, rationales, statements, SOPs, ... in order to maintain compliance to regulations, guidelines, J&J policies and standards.
* You prepare for regulatory and customer audits and inspections together with the involved qualification teams.
Education & experience
* Master degree in technical / chemical / pharmaceutical area or equivalent through experience.
* A minimum of 2 years experience within a GMP production/lab area and/or experience in qualification processes in pharmaceutical area is required.
* Previous experience in a QA function is preferred.
* Previous experience with lab equipment qualification is preferred.
* Ability to manage QA aspects within a cross-functional organization, with different priorities, tasks and deadlines.
* Excellent verbal and written communication skills in Dutch and English
* Focused on collaboration and teamwork
* Action-oriented and focused on finding solutions
* Strong quality mindset
* Credible and able to remain cool under pressure
* Influencing and negotiation skills
* Mindset for continuous improvement, innovation and process optimization.
Janssen Pharmaceutica N.V. (7555)