Senior Qaulity Specialist OTC/Medical Devices

at  Perrigo

DESCRIPTION OVERVIEW

Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the former Omega Pharma, the European branch is today present in 30 countries with a strong local anchorage. You know us from brands like Physiomer, NiQuitin, XLS Medical, Zaffranax, Arterin, Dermalex, Biover, Galenco, Davitamon, Ymea, Lactacyd,,…
Perrigo is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture.
Do you want to act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Central QA CSCI & Country QA group?
Do you like to ensure compliance of the product portfolio with applicable regulations and quality standards?
Working within the Quality Assurance department and acting as a team lead at Perrigo might be your next career challenge!
Join our team and help us bringing our goals into practice.

EXPERIENCE REQUIRED

• Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry … or equivalent through experience
• Minimum 3 to 5 years of experience in quality assurance
• Good knowledge of the relevant European regulations (MDR, ISO 13485, GMP,…)
• You are a self-starter, capable of working autonomously at corporate level
• You are a clear communicator, practical and solution orientated
• You are enthusiastic and hands-on
• You have strong project management skills & team worker in a multicultural environment
• Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills
• You are fluent in spoken and written English. Other languages are an asset

THE TEAM IS REPRESENTATIVE WITHIN PRODUCT CATEGORIES AND RESPONSIBLE FOR ALL QA MATTERS ASSOCIATED WITH THESE:

• Act as quality representative in product related category meetings
• Prepare and maintain Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors)
• Assist with due diligence and integration of new product developments / new product introductions
• Support technical transfers, qualification and validation work
• Participate to Change control process for the related Products and follow-up implementation of changes
• Support in stability programs and review of stability results
• Support QA activities in data and document collection for regulatory purposes, including but not limited to maintenance of technical files
• Provide input to risk management plan and risk management file in line with ISO14971
• Perform and support technical assessments of products, processes and documentation