Senior Qaulity Specialist OTC/Medical Devices
Perrigo
Ghent, Belgium
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
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