General Objectives

• Supports the operational teams of Filling & Packaging L&C’s.
• Represents operations in project teams in his / her area.
• Investigates incidents/discrepancies in collaboration with Quality Assurance for quality and compliance issues and taking appropriate corrective actions to prevent them from reoccurring.
• Identifies and implements improvements in areas of quality, compliance, costs, stocks, yields, competencies and customer service.
• Acts as a driving force in achieving the lean goals & objectives of the department.
• Ensures that the yearly budgeted volume is produced in accordance with priorities and updates set by the planning department.

Specific Objectives

• Supports the operational teams Filling & Packaging by:
• Identifying and implementing improvements in terms of safety, quality and cost.
• Leading quality / complaint investigations executed by a multidisciplinary team.
• Leading non-conformance reduction projects
• Contributing to the documentation of events / deviations.
• Writing and assessing change controls for Operations.
• Delivering input to Master Data department when changes in batch documentation are applicable.
• Updating procedures.
• He/she drives the team spirit and a positive culture of collaboration within the own team/organization.
• Effectuate and maintain the positive quality culture through a pro-active attitude and drive. Create a quality-focused mindset and a sense of ownership in the whole team.
• Take initiative in implementing quality and other process improvements by involving all members of the team.
• Connect with other departments to share best practices and look for solutions.
• Acts as a driving force in achieving the lean goals & objectives of the department by:
• Identifying and implementing improvements in terms of safety, quality and cost.
• Coordinating the Value Stream Mapping process for his / her area.
• Supporting the Kaizen teams.
• Building up technology expertise for the area of Filling & Packaging
• Be one of the department’s spokespersons in case of health authority inspections, internal audits or visits.
• Represents operations in project teams in his / her area, ensuring that impact on operations is correctly assessed and all actions are executed.
• Helps ensure that all production related activities are executed in the most efficient way, taking all ethical, legal and economic factors into account.
• He/she actively lives the credo and J&J values and continuously expands the knowledge and expertise of his/her team
• EH&S² responsibilities
• Actively deploys the company’s prevention strategy, the safe behavior program, prevention share, etc.…
• Acts as a role model and support risk analyses, check rounds, incidents investigations
• Provides the appropriate instructions and training, adequate guarding around equipment and personal protective equipment and other necessary means to create a safe, healthy and positive work environment
• Involves and consults operational staff for all aspects of prevention, provide information and feedback
• Measures and evaluates the EH&S² performance and ensures appropriate behavior
• Monitor compliance with prevention procedures and work methods
• GMP Responsibilities:
• Actively deploys the company’s compliance strategy and culture
• Acts as a role model and performs risk analyses, check round, incidents investigations
• Provides the appropriate instructions and training and adequate supervision
• Involves and consults operational staff for all aspects of cGMP, provides information and feedback
• Measures and evaluates the cGMP performance and ensures appropriate behavior
• Monitors compliance with cGMP

Qualifications
Profile required for this position
Knowledge

• Technical skills and knowledge
• Insight in microbiology and hygiene
• Insight in technical aspects of production
• Clear understand of c-GMP regulations
• Clear understanding of prevention regulations
• Project management skills
• Insight of costing and budget processes

Process/problem solving skills

• Insight in various problem-solving methods (e.g. RATIO, FMEA, RCPS)
• Process thinking/analytical skills
• Strong passion for innovation, out-of-the-box mindset
• Strong partnership with Quality, Engineering, Technical Services departments

Communications/people skills

• Team player
• Good communication techniques and presentation skills

Education

• Industrial engineer, bio-engineer, pharmacist or equal by experience

Languages

• Dutch and English

System knowledge

• Docspace
• Compliance Wire
• ePRS / Spotfire
• Trackwise
• SAP (general)
• Microsoft Office

Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Production
Requisition ID
1905772285W