Quality Assurance Associate

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 Compeed, Ella One, Norlevo, 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.

The Quality Assurance Associate is in charge of Perrigo Medical Devices products for:

• CMO Management: responsible for all QA activities associated with the management of the CMOs under his/her responsibility.
• Product Quality Management: responsible for all QA activities related to the products under his/her responsibility associated with the development of new products, manufacturing line transfers, stability studies and validation activities.
• Technical File redaction: responsible for the preparation of the Manufacturing, Quality and stability sections of the technical files related to the products under his/her responsibility
• Support the maintenance of the Quality Management System: ensure that the SOP and templates used in daily activities are up to date and compliant with the relevant standards.
• Coordinate operational activities: collaborating with all the relevant stakeholders, the Quality Assurance Specialist ensures that Perrigo products are at any time compliant with the relevant regulation and standards. He/she provides QA expertise to all departments.

Scope of the Role

1.CMO Management
a.Prepare, maintain and control Quality agreements.
b.Build and maintain relationships with the relevant stakeholders at the CMO site.
c.Review, challenge and approve the protocols/reports provided by the CMO.
d.Facilitate the communication between the CMO and Perrigo

2.Product Quality Management
a.Preparation, review and approval of validation activities
b.Follow-up on ongoing stability studies
c.Active participation in the dedicated product category meetings
d.Participation in transfer activities, if needed
e.Reporting to line manager of critical activities and projects status

3.Quality Management System
a.Responsible for updating relevant SOP under his/her scope
b.Maintenance of database and documentation
c.Ensure a close follow-up and a timely execution of all Quality processes related to his/her products.
d.Contribute to the identification of GAP and point of improvement in the QMS
e.Support during Notified Boby audits, if necessary

4.Coordinate Operational activities
a.Open and manage non-conformities, deviations, change controls, CAPA and other relevant QA processes
b.Ability to perform audits of manufacturers under ISO13485 and MDR scopes
c.Support business needs

Experience Required

Scientific background, with 8 to 10 years of experience in the life-science industry and Medical Devices management
•Ideally, > 5 years in quality assurance.

Skills :
Mandatory :
•Good knowledge of ISO13485 and MDR
•Medical Devices experience (manufacturing and technical files)
•Certified ISO13485 auditor
•Knowledge about Cosmetics, Biocides or Food supplements is a plus
•Good IT knowledge and skills

Profile:
-Self-starter, capable of working autonomously at corporate level.
-Clear communicator, practical and solution orientated.
-Enthusiastic and get the job done.
-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 speak and write fluently English. Other languages are an asset.
-An innovative frame of mind – open to applying creative techniques to find a solution