Quality Assurance – Complaints Management Intern

Quality Assurance Complaints Management Unit is part of the Parma Quality Operations group that supports the Parma Plant regarding all quality and GMP (Global Manufacturing Practices) matters.

The team is responsible to ensure the implementation of the provided standards, handle and coordinate the management of Complaints received from the market, with a focus on both the resolution of the critical issues to guarantee patient safety and to assure the best quality and efficacy of Chiesi’s products.

The Intern will be in introduced in a dynamic and fast paced environment with the opportunity to support the activities of the Complaints Management Unit developing a good knowledge of Manufacturing processes, GMP regulations and Quality System guidelines.

In particular, the intern will support the Complaints Management Unit on the following activities:

• Evaluate complaints notification upon receipt

• Verify complained samples to correctly address investigation

• Contacting and following up with Complainants about status of investigation

• Checking the management timing for complaints activities

• Understand production processes and identify tendencies

• Develop better product knowledge

• Identify areas of improvement to adjust processing and control procedures

• Assure the correct archiving of GMP documentation

The intern will:

• Receive appropriate training on Trackwise, the quality management system for the management of Complaints and CAPA

• Develop good knowledge of the GMP regulations

• Interact with many internal and external stakeholders like Quality Control, Corporate Quality Assurance; Supply Chain, International Markets Development Division, Chiesi Affiliates worldwide and Service Providers.

Education: Master Degree in scientific disciplines (CTF, Pharmacy, Biology, Biotechnology, or equivalent).

Technical Skill

Proficient with Microsoft Office suite (especially Excel)

Basic knowledge on manufacturing processes and GMP regulations is a plus.

Soft skills:

• Good planning and organizational skills

• Ability to analyse, synthesise and to link and interpret different information

• Ability to work in a team

• Interaction ability with internal and external stakeholders

• Accuracy and focus on quality

Languages: English: Fluent.

Contract and Benefit:

6 months internship

Monthly Reimbursement of 1000 Euros

Meal vouchers for each day of remote activities

Free access to internal canteen for lunch

Free shuttle reserved to Chiesi employees from railway station to Chiesi Parma Production Plant and/or free pass to the urban public service