QA Csv Systems Associate
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.
Location:
Ghent, Belgium.
We offer a Hybrid working schedule, a mix of onsite and remote working each week.
Scope of the Role:
- Represent QA in computer system validation projects including change controls, deviations and periodic reviews.
- Provide support with guidelines and regulations such as GAMP 5, EU GMP Annex 11, and FDA CFR Part 1
- Act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Perrigo CSCI group.
- Keep going awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD).
- Maintain databases and documents according to good documentation practices and record retention procedure.
- Support in the maintenance of Quality Systems, including electronical systems (Trackwise, LMS, ).
- Provide QA training to the entire group (European branch of the Perrigo Company) regarding QA systems and processes and procedures and evaluate training effectiveness, including the creation of powerpoint presentations, online recorded trainings, etc.
- Initiate and followup Change Controls together with the Regulatory Affairs team.
- Ensure adherence to critical procedures and compliance to requirements for record retention.
- Set up and maintain Quality Agreements with thirdparties (contract manufacturers, logistic service providers, distributors).
- Represent QA in computer system validation projects including change controls, deviations and periodic reviews.
- Investigate quality incidents, deviations and complaints, identify and followup CAPA's and supplier improvement plans together with thirdparty contract manufacturers.
- Evaluate and followup Change Controls together with the Regulatory Affairs team.
- Agree stability programs and review stability results.
- Be part of thirdparty qualification and regular thirdparty auditing.
- Assist in performing internal QA audits.
- Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions.
- Provide support in establishing and maintaining the ISO 9001 and ISO 13485 Quality Management System
- Provide support with guidelines and regulations such as GAMP 5, EU GMP Annex 11, and FDA CFR Part 1
- Provide input to risk management plan and risk management file in line with ICH Q9 and ISO 1497
- Provide input for analysis of data and/or management review
- Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
- Support QA in data and document collection for regulatory purposes.
- Coordinate Change control process and followup implementation of changes.
- Provide evidence to perform review of implementation and effectiveness with regard to corrective and preventive actions.
Experience Required:
- Bachelor degree in IT, engineering, biochemistry, chemistry or equivalent through experience.
- You are fluent in spoken and written English, other languages are a benefit.
- At least 25 years relevant experience in Quality systems and preferably with focus on Computer system validation
- Knowledge of the relevant European regulations for pharmaceutical products (GMP specifically Annex 11, GDP), Medical Devices (MDR, MDD, ISO13485, ISO14971), Food, Food Supplements (HACCP, ISO Cosmetics (ISO 22716), GAMP 5 principles and EU GMP annex 11 is desired
- Knowledge of FDA regulations (especially CFR Part 11) for pharmaceutical products is 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.
- 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 A
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