Quality Assurance Lead Manufacturing - Lyon, France - Recordati Group

Recordati Group

Entreprise vérifiée

Lyon, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve.

We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple.

We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege.

Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves.

This drive will never stop.

Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life

Role Purpose

The QA lead manufacturing will be responsible for product quality processes according to quality standards and will ensure that all administration relating to these tasks is maintained and updated as required.

The QA lead manufacturing will manage the quality processes related to the products distributed by the company: Trend analysis, writing of Annual Product Quality Reviews and review of batch files.

The objective is to ensure compliance of these activities with Good Manufacturing Practices, as well as with applicable national and international regulatory directives.

Key Responsibilities

In accordance with the annual product reviews received from the manufacturers, prepare and maintain the annual Product Reviews for each product on time.
Responsible for reviewing production batch files in accordance with the marketing authorization dossier,
Responsible for the release of batches of medical devices.
Responsible for the investigation of complaints and deviations related to the Products, ensuring their correct and complete registration, participating in the completion of the investigation (internal and external) and the closure
Create and articulate a vision for oneself and for the team, in accordance with the objectives and the mission statement of the Company
Provide support for the development and continuous learning of all team members
Participation and contribution at weekly internal Management Team Meetings and periodic business review meetings.
Support special projects requiring QA input.
Ensure compliance with regulatory issues and changes, ensuring that updates are communicated and applied in line with the business requirements.
The QA manager will contribute to KPIs and metrics to measure trends and performance of the QA System and to provide information to the Leadership Team.
Consults and mobilises others during various phases of the problemsolving process
Demonstrates creative and innovative thinking to find best solutions

Education, Skills and Experience:

PhD in Pharmacy.
Minimum of 6 months of professional experience in the pharmaceutical industry, ideally in production
Clear understanding of the environment, regulations and constraints of the pharmaceutical industry
Very good knowledge of English (written and oral)
Demonstrated autonomy in daily activity
Positive thinking and enthusiasm, team spirit, cooperative
Flexible and adaptable
Strong interpersonal skills with ability to work with others as well as independently
Computing: PC literacy (Windows environment: Word, Excel, PowerPoint, Internet Explorer).
Keep informed of good industry practice, and those applicable to your mission

At Recordati we believe in people Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion.

We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer.

We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.