Senior Validation Specialist

Senior Validation Specialist; Schaffhausen (Switzerland); 9 months; 80-90/hr CHF

My client, a well known pharmaceutical company is looking for a Senior Validation Specialist for a medium-long term contract to be based at their site in Switzerland. They require someone who is able to 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

This is an exciting opportunity to work for a company who embrace research and science and where you will be able to touch the lives of over a billion people every day.

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. Experience 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 experience as a Subject Matter Expert on Validation Quality System during Inspections.
*Has experience 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, ie 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, and has a strong international network on validation.
*This position requires a strong analytical 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 eg 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, eg biosciences, pharmacy, analytical chemistry, process technology, engineering, supplemented with additional training during working-life
*Experience in a pharmaceutical or related industry, of which at least a few 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

Qualification:
*FDA regulations
*GMP (Good manufacturing practice)
*Pharma Experience

Non-Technical profile requirements:
*Some flexibility in working hours is required
*Must be able to work on multiple simultaneous tasks with limited supervision;
*Quick learner, motivated self-starter;
*Excellent customer service, interpersonal, communication and team collaboration skills;
*Able to follow change management for internal guidelines
*Language proficiencies: - English and Swiss German spoken and written