Laboratory Equipment Qualification Engineer - Beerse, Belgium
- Beerse, (BEL)
- €28 - €33 Per Hour
- 12 Months
- Start date: ASAP
- Ref: 723
- validation
- pharmaceutical
- compliance
- qa
- change control
- regulatory inspections
- labelling
- gmp
- pdms
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). You are QA Support related to qualification of our systems and processes and from this expertise you are
• QA support for production, engineering and qualification teams.
• QA support for change control and event /deviation handling and provide advice from your quality expertise.
• QA qualification support during changes and strategic projects for the site.
Your main responsibilities consist out of
• Assuring that the qualification status is maintained during assessment and execution of changes and projects.
• Review and approval of qualification documents such as master documents, validation plans, protocols, reports, rationales, SOP’s in order to maintain compliance to regulations, guidelines, J&J policies and standards.
• Guarding the cGMP aspects in the different qualification projects
• Review and approval of change controls related to lab equipment
• Review and approval of qualification discrepancies and related corrective actions
• Review and approval of Periodic System Quality Reviews (PSQR) and Validation Master Plans (VMPs)
Education & experience
• Master degree in technical / chemical / pharmaceutical area or equivalent through experience.
• Working experience in regulatory controlled environment: 21 CFR Parts 210, 211; EU Directive 2003/94/EC and annexes; Eudralex Volume 4 GMP guidelines and annexes.
• Working experience in regulations regarding electronic data: 21 CFR part 11, GAMP’s.
• Previous experience in a QA function is preferred.
• Previous experience in qualification is preferred.
• Demonstrated ability to manage QA aspects within complex projects, priorities and multiple tasks.
• Persuasive and credible to act as subject matter expert during internal and external regulatory inspections
• Influencing and negotiation skills
• Mindset for innovation and optimization.
• Excellent verbal and written communication skills
• Collaboration and teaming skills
• Focused on solutions
• Strong quality mindset
• Fluent in Dutch and English
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
