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Senior Qaulity Specialist OTC/Medical Devices

  • Perrigo
Ghent, Belgium
Full-time
Published:
  • Perrigo
Ghent, Belgium
Full-time
Published:

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.

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