Senior Quality Specialist

il y a 1 mois

Châtillon, France Perrigo Temps plein

 At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

 

Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care.

Description générale

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

 

Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care.

 

In this position you will act according to the defined Quality Assurance (QA) vision, strategy and standards for the integrated corporate & country QA group and ensure these objectives are consistently met, you will ensure compliance with Eudralex Volume 4, ISO22716, EC1223/2009 and other regulatory requirements, ISO13485, ISO 14971 and other harmonized standards and MDR/MDD directives and other regulatory requirements.

Périmètre du poste

In this position, you will be 

  • Responsible for the Quality Management System (QMS) with regards to the several statuses of the entities managed (monthly and yearly reviews, continuous improvements, and training)
  • Ensure the QMS is established, compliant and maintained to current GMP, GDP and ISO certification governing the different status of products and organizations
  • Responsible to leads the harmonization of quality management systems to become ‘One Perrigo’ proposing a plan to initially streamline processes that enable smoother ways of working for internal stakeholders whilst respecting existing certifications in the short term. 
  • Responsible for EDMS Administration and its roll out to other entities
  • Responsible to pilot the Change Control Process
  • Process owner for the Quality Management Process
  • Responsible for the follow up of KPIs related to ISO13485 activities with all process pilots
  • Contribute to the management and investigations of internal deviations and their related CAPA
  • Responsible for training oversight of the QMS for all Perrigo Global CSCI organization
  • Provide QA training to the entire group regarding QA systems and processes and evaluate training effectiveness.
  • Ensure the good application of all controlled documents
  • Responsible for ISO13485 related internal and external audits
  • Support the Quality Director for any audit/inspection at all sites and ensure audit readiness
  • Prepare, participate and lead as appropriate all Management reviews 
  • Act as Deputy Person for Regulatory Compliance (PRRC)
  • Manage a team of 5 to 6 people (2 different locations)
     
Expérience requise

•    Master’s degree + 5/6 years minimum degree in science related subject and quality
•    At least 8 to 10 years relevant experience in Quality Management System activities
•    You are fluent in spoken and written in French and English (other languages are a benefit).
•    You are comfortable working in an international environment
•    Deep knowledge of Quality regulations:  Medical Devices (MDR, MDD, ISO13485, ISO14971), pharmaceutical products GxP (Good Practices), Cosmetics (ISO 22716), Food Supplements (HACCP, ISO 22000)
•    ISO13485 auditor experience will be a plus
•    Management of Quality and Office Tools
•    Management experience required 

 

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". 

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application.  (The SAVE button will only save your profile information but not submit an application for this open position.)  Thank you.

 

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


 

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo. 

 

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". 

 

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application.  (The SAVE button will only save your profile information but not submit an application for this open position.)  Thank you.

 

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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