Validation Specialist - Senior

Beschreibung

Validation Specialist - Senior

Develop, maintain and improve the Validation Quality system for compliance, effectiveness and efficiency purposes. Provides expertise to the management and validation executing departments regarding validation issues.

The scope of the Validation Department is focused on the Verification phase and the Process Validation in the Life-Cycle of a production system. Analytical Validation is out scope of the departmental tasks. Responsibilities:
Provides expertise on Cleaning Validation, Hold Time Validation, Mixing Validation, Process Validation, Packaging Validation

Assures compliance to regulations. Experiance with the FDA Process validation Guideline is a must. Intervenes and act as main focal point in case of (complex) studies or issues.
Maintains and Improves the Validation Quality system for compliance, effectiveness and efficiency purposes.
Has experiance as a Subject Matter Expert on Validation Quality System during Inspections.
Has experiance with dtV CTQ and CQA
Participates in setting directions for the Validation Department as well as priorities of activities. ? Is not accountable for the line-managerial tasks, i.e. people development, illness, appraisals. The focus of the position is on developing, maintaining and improving validation activities to meet with current/future industry and regulatory standards. The jobholder communicates and coordinates with colleagues from all departments within Jannsen sites, and has a strong international network on validation. This position requires a strong analytisal power and independent thinking to find structural and scientifically sound solutions for the issues identified. The jobholder performs all mentioned tasks above independently. However, in critical steps the (Sr.) Manager Validation will be involved. It is the jobholder?s responsibility to observe the necessary caution and carefulness in order to avoid dangers for the safety or health of themselves or others and for the environment, when carrying out activities. This implies e.g. that machines, apparatus, tools, dangerous compounds, transportation means and other expedients must be used properly, when necessary with use of the prescribed protective means. The jobholder shall not change or remove installed safe guards and will use them in a safe way. The jobholder immediately acknowledges management of dangers for the safety, industrial hygiene and the environment. Furthermore the jobholder should adhere to all safety, industrial hygiene and environmental procedures.

Requirements: ? Bachelor degree or proven qualification otherwise in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology, engineering, supplemented with additional training during working-life. ? At least 3 years experience in a pharmaceutical or related industry, of which at least 2 years of validation experience ? Experience in a multinational work environment/company ? Analytical, innovative and pragmatic thinking ? Proven experience in a several fields of validation ? Manage and resolve conflicts within fields of expertise ?
Set up and maintain networks within fields of expertise. ?
Highly result driven
Fluently in English
Excellent communicator
Experience with Project Management'

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