Senior Qaulity Specialist OTC / Medical Devices

Location:

Ghent (9050) – Belgium

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Manufacturing Jobs

Advertiser:

Perrigo

Job ID:

130933136

Posted On:

11 August 2024

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. 

Scope of the Role

You will lead a team of people (up to 8 people)

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
Ensure compliance to design and development of medical devices:

-Support during day-to-day operations (batch release of MD, complaint investigation, rework, Quality Management improvement activities)
-Keep going awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD)
-You will also ensure the effective investigation (including non-conformity handling) of complaints and other incidents, including root cause analysis and defining CAPAs for short term and long term improvements
-You will be maintaining databases and documents according to good documentation practices and record retention procedure
-You will support internal and external audits

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
What we can offer you:

-Perrigo offers you a challenging position within a strong and dynamic company
-A professional environment offering you the opportunity to boost your career through training, coaching & support, learning on the job
-A competitive compensations and benefits package for the required level and experience
-The opportunity to work in a hybrid working model as part of our selfcare and wellbeing strategy. Hybrid working combines caution and flexibility with passion and energy to make our vision a reality

Location: Ghent, Belgium.

We offer a Hybrid working schedule, a mix of onsite (3 days) and remote (2 days) working each week.

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