Description
Quality & Compliance Analyst - Beerse, Belgium/8 Months Contract/Up To 34 EUR (Per Hour)
General Objective & Responsibility
This Quality & Compliance Analyst function will support the implementation of the Proactive Product Quality Scan (PPQS, a risk assessment tool to evaluate the quality and compliance level of the products) and Heatmaps (reporting tool for the risk status of a group of products) in a new IT system (Metric Stream). These activities will be done as part of the End-to-End Risk Management project within the Quality organization.
This function will also support the PPQS process owners in the execution of general activities for PPQS and Heatmaps
Specific Objectives & Responsibilities
- Participate in project team and represent PQM for PPQS and Heatmaps
- Support the implementation of PPQS and Heatmaps in the selected IT system (Metric Stream) by for example:
- Providing input/feedback to the IT team
- Participating in the execution of User Acceptance Testing
- Leading/supporting the development of the related SOP's and WI's
- Creating training materials
- Providing training to the end users
- Support in the execution of the PPQS process
- Prepare PPQS related reporting metrics
- Support the quarterly update of product risk Heatmaps
Knowledge & skills
- Strong analytical thinking, experience with risk assessment and strong communication skills
- Excellent verbal and written communication skills to negotiate and communicate with external and internal customers and partners in Dutch and English
- Strong computer skills: in-depth knowledge of the standard software systems (eg MS Office), quickly understanding and using new software systems
- Ability to work across organizational boundaries and cultures in a Matrix organization.
- Ability to work and communicate in a virtual environment.
- Knowledge of cGMP, pharmaceutical legislation, regulations and guidelines (CFR, ICH, Ph.EUR, USP,) is an asset
- Experience in pharma or biotechnology industry is an asset
- Customer Focus: demonstrates an understanding for the needs and expectations of customers and makes them a high priority. Understands sense of urgency. Maintains contact with customers and understands customer needs in order to take the right decisions.
- Communication and Influencing: Ability to bring ideas to meetings, ability to explain the process to the customers.
- Change Management: Ability to recognize resistance/and lead others through the change management process, ability to influence others to accept the change
- Global Mindset and Management: Global experience and cross cultural understanding is an asset
Education degree
- BA/BS required, Master desirable (Pharmaceutical, Chemical or Biological Sciences)
- Languages - Dutch, English.
The Company
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.