Belgium Job Openings
Perrigo
Senior Qaulity Specialist OTC/Medical Devices
Ghent
September 9, 2024
Description Overview
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
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
- 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
- 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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