Sr Quality System Specialist

il y a 14 heures

Le PontdeClaix, France BD Temps plein

**Job Description Summary**: Provide GxP and Quality Management Systems awareness and education among PS sites to drive comprehensive and efficient simplification program in alignment with one PS Quality Management System strategy
- will join our Worldwide Quality Systems department.
- will be responsible for translating GxP and ISO 13485 requirements into engaging educational programs
- will select appropriate instructional methods, defining time frames, and preparing training materials in appropriate formats (physical and digital)
- will design and develop learning and practicing experiences to facilitate learners in acquiring Quality knowledge, skills and competencies in an effective and appealing manner.
- will work closely with all the Business process Owners, Leaders, Managers and local training Specialists to establish thru a risk-based approach, the overarching Learning and Development strategy.

Ensuring that quality mindset is high, consistent, impactful, rigorous, and continuously evolving with the GxP environment. This includes language and culture differences and delivery methods.

Main responsibilities
- Define and Lead quality awareness and training strategy for PS BU
- Design and develop learning and practicing experiences
- Plan and deploy training and awareness plan across the PS sites
- Coordinates and/or hosts external audits (customer, government, etc.);
- Provide support to sites on explaining Quality System and regulations expectations Trend QS data to define a risk based training plan
- Ensure harmonized training plan deployment among sites
- Stay up-to-date on industry best practices and regulations to support an effective quality system;
- Act as one point of contact for supporting questions from Customers and external Auditors related to quality systems and regulation
- Support global quality initiatives to enhance and harmonize the quality system across the business

You are graduated in Engineering or similar scientific discipline,

**Experience**:
Minimum of 5 years in a regulated industry.

You have a strong experience in educating adults.

You are familiar with several processes to educate the organization in an effective and efficient manner.

You have the technical skills to design and deploy training and associated communication strategies using all available supports.

You have Project managements experiences

You have knowledge of regulations preferably those of medical devices (such as ISO13485, 93/42/EEC, 21CFR820) or pharmaceutical products (Eur GMP, 21CFR210/211).

Finally, you speak French and English fluently, Spanish is a plus.

Soft skills

Your pedagogic skills are recognized.

You know how to deploy efficient learning and communication plans.

**Primary Work Location**: FRA Le Pont-de-Claix Cedex

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