Corporate QA External Manufacturing Sr. Specialist - Parma, Italia - Chiesi Farmaceutici

Chiesi Farmaceutici

Azienda verificata

Parma, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Date:
Apr 14, 2023

Department:
Corporate Quality Operations

Job Type:
Direct Employee

Team:
Quality

Contract Type:
Permanent

Location:

Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group).

To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas:
Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards.

We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors.

Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Global Manufacturing Division

Chiesi Group has three production plants: Parma (Italy); Blois-La Chaussée-Saint-Victor (France); Santana de Parnaíba (Brazil). The plants produce a total of over 110 million units per year.

The production plant in Parma covers a total area of more than fifteen thousand square meters and it is the strategic hub for the production and distribution of our products, being an international supply center that exports to more than 80 countries.

The Parma plant produces solid medicinal products, such as tablets and inhaled dry powders; inhalation solutions and suspensions, either pressurized or sterile single-dose vials; vials of sterile suspension for endotracheal administration; liquid forms such as drops, syrups and nasal sprays.

Santana produces pressurized solutions and suspensions for inhalant therapy (MDIs) and supplies both domestic market and Group's Affiliates and exports to licensees and distributors.

Blois specializes in Dry Powder Inhalers and final assembly stages of the Metered-Dose Inhalers (MDIs), supplies Group's Affiliates and distributes directly to clients at a local level and in export markets.

Who we are looking for

Purpose

The person will support our Corporate Industrial Production Outsourcing Department in managing CMO's Quality Activities.

Main Responsibilities
Establish relations with the assigned CMOs to monitor their Quality Management System and ensure appropriateness of operations.

More specifically he/she shall review deviations (as per Quality and Technical Agreement) to ensure that they are properly bracketed and investigated and that appropriate CAPAs are implemented; he/she shall partner with Corporate Manufacturing Technology in assessing the GMP impact of change controls issued either by the CMOs or by Chiesi, ensuring that implementation plan is performed as accurately as requested by corporate; he/she is also ensuring that complaints - when appropriate - are investigated by CMOs in compliance with cGMPs and that the associated CAPAs are effective.

Review and report PQRs (APRs) into corporate systems and provide Corporate with appropriate metrics for the corporate quality council.

Cooperate with GMD External manufacturing and Manufacturing technology functions in: due diligence for new CMOs and supervision of quality aspects of their operations; support for M&A when requested; audit of suppliers and distributors in conjunction with Corporate Quality systems; Tech Transfer support.

The person shall be willing to travel up to 30% of the time.
Experience Required
At least 7 years of experience in QA in a GMP-regulated environment;
Experience in managing CMOs or external stakeholders;
Experience related to manufacturing processes of sterile products.
Education

University Degree in scientific disciplines; post-doctoral studies are welcome.

Languages

Fluent English (both written and spoken)

Technical Skills

Knowledge of the applicable international regulations and Guidelines, in particular the EU, US FDA and Health Canada's GMPs.

Soft Skills
Communication skills
Attention to details
Learning agility
Problem solving
Team working

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.

In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.

Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the qualit