Quality Specialist Milano

Quality Specialist
Milano
Lombardia, Milano

Quality Specialist

- _ Location: Milano, Italy_

- _ 60% Remote working_

- _ Job type: Full time_

About the job

- At Sanofi Consumer Healthcare_

- , we have one shared mission - we work passionately, every day, to 'serve healthier, fuller lives' now and for the generations to come. _

- In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view. _

- Everything we do is centered around people's interests - our consumers, our customers, healthcare professionals, and our employees - across the world. _

- We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu. _

- We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best. _

Main responsibilities:

- Support the Country Quality Manager in leading and managing the implementation and maintenance of Country Quality System in accordance with Sanofi Quality reference standards across the CHC country organization;

- Support implementation and maintenance of ISO 9001 certification of the Affiliate;

- Participation in promoting Quality Culture & Mindset, participating to quality initiatives and training and acting as a reliable quality interface across the country organization;

- Country Quality Documentation management system: support deployment at local level of Country Quality documents related to GxP and health-regulated activities; support to GxP functions during internal audits and to country functions that need to develop or update local SOPs;

- Participation to country audits and GxP regulatory inspections: provide support for preparation and updating of the monitoring file called "Inspection Readiness Tools for Affiliates".

Participation to internal quality audits to all GxP relevant processes, according to the audit annual plan and to audit key for local GxP and health-regulated subcontractors directly managed by the country.

- Support evaluation of complaints trends that may affect the country quality system and communicate to Country Quality Manager to find improvements;

- Training: support in preparation of annual quality training plan, involving colleagues from other functions.

- Country Quality review: support Country Quality Manager in organizing and collecting data required by applicable Global procedures and standards.

Deviation and corrective actions (CAPA) management: support and implement proper management of deviations and CAPAs including those related to audits and inspections findings, according to local SOPs.

- Country Quality Agreements: ensure that valid and signed quality agreements (with the country as contract giver) are in place (with Sanofi manufacturing sites, distribution centres as well as with third party sites) for all GDP/GMP activities under the responsibility of quality within the country organization;

- Quality of products: contributes to products complaints management according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality Functions, Manufacturing sites and CMOs.

Support in managing quality alerts and products recalls as per global processes and local SOP.

Participates to quality oversight and accordance to local regulations and SOPs on management of product distribution issues, including temperature excursion, returns, repackaging operations, shipment under quarantine and consequent release to the market.

- Product quality review: support Country Quality Manager in the quarterly update of product portfolio, list of QA/ S&TCs and quality events/recall in order to perform MAH evaluation of Italian products.

About you

- Experience: Experience in Quality Assurance/Quality Management in pharmaceutical industry, with experience in GMP/GDP/production is appreciated.

- Soft skills: problem solving, data analysis and critical thinking capabilities.

- Technical skills: Pharma Regulation Frame and environment, knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) knowledge, ISO standards 9001.

- Education: Degree in Scientific disciplines.

- Languages: Good knowledge of English (Italian is a plus).

Pursue progress, discover extraordinary

Better is out there.

Better medications, better outcomes, better science.

But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.

So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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