Senior Quality Specialist
il y a 1 semaine
Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.
Help us do it.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.
Location:
Ghent, Belgium.
We offer a Hybrid working schedule, a mix of onsite and remote working each week.
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 thirdparties (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 followup 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 ISO1497
- 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 nonconformity 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 selfstarter, capable of working autonomously at corporate level.
- You are a clear communicator, practical and solution orientated.
- You are enthusiastic and handson.
- You have strong project management skills & team worker in a multicultural environment.
- Persistent drive for results in a fastpaced 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.
- We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in _
_English__ and _
_Spanish__ and will be provided in other accessible forms for persons with disabilities._ #DIV
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