Senior QAulity Specialist OTC/medical Devices

Il y a 3 mois

Gent, Belgique Perrigo Temps plein

**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, chemistryor 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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