Quality Assurance Professional - Shop Floor
ITALY Sales
Job description
· Job Purpose:
· Maintain & Manage QA product shopfloor to ensure building of quality into the product in order to guarantee the conformance of the final product with its predetermined specifications and compliance to GMP regulations, Sanofi industrial quality and compliance directives & guidelines and Local national requirements.
KEY RESPONSIBILITIES AND DUTIES:
· Participation in Investigations of Site Deviations:
· Conduct investigation assigned impacting product quality are investigated to evaluate the root cause, corrective actions and preventive measures needed to prevent re-occurrence.
· Shopfloor Activities:
· Review of the batch record received in the assigned area of responsibility before release.
· Maintain compliance to local and Sanofi regulations in manufacturing areas.
· Prepare assigned PQRs.
· Retain sample review.
· Implement the assigned CAPAs and ERs.
· Review and report the status of the quality stock at the QA level.
· Review the assigned documentation as assigned on Qualipso system.
· Update and conduct the shopfloor +QDCI meeting as assigned.
· Quality tours
· Conduct Quality tours & process observation within assigned area.
· HSE Responsibilities:
· Commitment to the appropriate PPE use.
· Follow the approved HSE policy and requirements.
· Following the statutory legislation concerning Health, Safety and environmental law.
· Others:
· Investigate in the received complaints from the market.
· Respect of company’s values, code of ethics and social charter.
· Respect of personal data protection charter.
JOB-HOLDER’s ENTRY REQUIREMENTS :
Education:
· Bachelor’s degree in pharmaceutical science
· Postgrad studies “ Master degree of pharmacology and toxicology “
Related Experience:
· QA, Shop Floor.
· QA, External Manufacturing.
· QA, Compliance.
· 6 Months – 3 years' Experience.
Special Knowledge/Skills:
· Shop floor activities.
· QA Documentation and compliance systems experience.
· Background knowledge in pharmaceutical industry & raw materials “API & Non-API”
· Decision making & problem solving.
· Risk management & Root cause analysis tools.
competencies:
· Stretch to go beyond the level we have operated at up until now
· Take rapid actions to meet the targeted and planned dates for each task.
· Act in the interest of our patients and customers
· Put the interests of the organization ahead of my own or those of our team
· Act for Change, strive for results, Cooperate Transversally, Commit to Customer
· Think Strategically, Lead Teams, Develop People, Make Decisions
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.