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Career Opportunities: Associate Computer System Validation (6309)

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Belgium

Offer summary

Qualifications:

Bachelor degree in IT, engineering, biochemistry, chemistry or equivalent, 2-5 years of relevant experience in computer system validation in Pharma/Medical Devices industry.

Key responsabilities:

Represent QA in computer system validation projects
Provide guidelines and support in regulations compliance
Ensure adherence to procedures and record retention
Conduct internal QA audits and third-party qualifications
Identify gaps in QA processes and lead improvement actions

Perrigo Company plc XLarge https://www.perrigo.com/

10001 Employees

See more Perrigo Company plc offers

Job description

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 or Chatillon, France

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 and Data integrity for CSCI
Provide support with guidelines and regulations such as GAMP 5, EU GMP Annex 11, and FDA CFR Part 11
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)
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 computer system validation and Data Integrity and evaluate training effectiveness, including the creation of powerpoint presentations, online recorded trainings, etc.
Ensure adherence to critical procedures and compliance to requirements for record retention
Be part of third-party qualification and regular third-party auditing for all topics related to Computer System Validation and Data integrity
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. related to Computer Systems and Data Integrity
Provide support in establishing and maintaining the ISO 9001 and ISO 13485 Quality Management System related to Computer Systems and Data Integrity
Identify gaps and areas for improvement in QA processes related to Computer system and handling and lead remedial actions and initiatives

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 2-5 years relevant experience in Computer system validation in Pharmaceutical and/or Medical Devices industry
Deep knowledge of FDA regulations (especially CFR Part 11), EU GMP Annex 11 and GAMP 5.
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 22000); Cosmetics (ISO 22716) 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 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