Quality Assurance Associate Milano

Quality Assurance Associate
Milano
Lombardia, Milano

Would you like to be in a business where you can make a difference - where your every effort and activity are recognized, where you contribute and develop the company?

QUALITY ASSURANCE ASSOCIATE Industry: Pharmaceuticals and Medical Devices Employment type: Full-time Seniority level: 2-4 years experience Location: Milan (Italy) – Home based smart working Travel time : max 10%    Job Description Manage the Italian subsidiary Quality Systems primarily in accordance with ISO 13485 – MDR regulation (Medical Devices) and cGDPs (Pharma).

Manage product certification process with Notified Body.

Handle deviations and non-conformities detected, ensuring the quality of the product output and verifying the effectiveness of the corrective actions taken.

Handle customer complaints with related investigation, corrective activities, response and closure complaints.

Handle changes and coordinate with external manufacturing.

Maintain local training compliance (ISO, GDP and MDR).

Lead and participate in internal audits, organize site Management Review and track and report KPIs.

Support supplier/outsourced activities qualification processes audits.

Develop Annual Product Quality Reviews and support product returns or recalls.

Support the Corporate Quality activities.

Support all other functions within the operations team where required: -      Operations -      Sales -      Marketing -      Regulatory Affairs -      Quality -      Device/Pharmacovigilance Support the growth of products within the group portfolio.

Experience required -      Bachelor's degree in Life Science or equivalent -      Ability to work flexibly and autonomously -      At least 2-4 years experience in Regulatory Affairs and in Quality Assurance for medical devices -      At 2-4 years experience in Quality Assurance for Pharma Distribution (IT GDP) -      Solid understanding of contemporary quality practices as they apply to manufacturing and commercial operations -      Proven knowledge in ISO 13485, ISO 19011, MDR 2017/745 and IT/EU cGMPs -      Proven experience working according to ISO 13485 -      Self-confidence and the ability to work with all levels of organization -      Operates in a way that never compromises ethics or integrity -      Fluent English   We Offer -      An exciting opportunity in a fast-growing international medical device and pharma company -      A modern working environment, with multicultural and dynamic teams -      Flexible working hours and a hybrid smart work policy   Line Reporting -      Corporate Quality Director     IMPORTANT NOTE: only direct applications will be considered.

About Primex Pharmaceuticals: Primex Pharmaceuticals is a leading global innovative anaesthesia company, expanding in paediatric pharmaceuticals.

Primex brings a portfolio of strong, trusted anaesthesia products helping patients undergo a wide range of medical procedures, including a novel, oral solution for paediatric sedation now approved in several markets in the European Union.

Primex Pharmaceuticals will continue to identify and bring to the market new medications that complete the Triad of Anaesthesia.

In addition, the Group includes a complementary range of local anaesthetics and dental products under the OGNA brand.

Primex Pharmaceuticals' global partner network operates in over 40 countries.

The company is headquartered in Switzerland; all Primex products are manufactured in Europe.

Primex Pharmaceuticals has proven underlying business operations and historical strong revenue growth.

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