Quality Assurance Expert

Fidia Pharma; Abano Terme; In loco; EUR 34.000 - 35.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical company in Abano Terme, Veneto is seeking a Quality Assurance Expert to manage quality assurance activities related to API GMP compliance. The ideal candidate holds a Master's degree and has experience in a similar role. The position offers a fixed-term contract, competitive salary, and various benefits including training and health programs.

Servizi

Collective Bonus

Company Welfare

Training and coaching programs

Staff discounts

Access to flu vaccination campaign

Competenze

• 1 year of work experience in a similar role in an API or medical device manufacturing company preferred.
• Knowledge of English at B2 level.

Mansioni

• Review of batch records for APIs and medical devices.
• Manage CAPA and deviations related to raw materials.
• Handle complaints for internal production APIs.

Conoscenze

Problem solving

Flexibility

Teamwork

Formazione

Master's degree in chemistry or related field

Descrizione del lavoro

Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint care, Eye care, Skin care, Specialty care, Health&Wellness care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries.

With the aim of strengthening the Quality Assurance Department, we are recruiting a

Quality Assurance Expert

You’ll collaborate with the team in the following quality assurance activities, related to API GMP Compliance.

Main responsibilities

• Batch record review of APIs and major components of Medical Devices and API PQR release.
• CAPA and deviations management for raw materials, intermediates and APIs/main components of Medical Devices.
• Issuing and reviewing quality system procedures with a particular focus on the raw materials production department.
• Review of inspection plans for raw materials, intermediates and APIs/main components of Medical Devices.
• Review of material master data concerning the raw materials production department.
• Complaint handling for APIs and other raw materials of internal production.
• Verification of Master Batch Record relating to APIs and main components of medical devices in accordance with internal procedures and regulatory documentation.

Requirements

• Master's degree in chemistry and pharmaceutical technology, chemistry, biology, biotechnology, chemical engineering, biomedical engineering or other scientific subjects.
• 1 year of work experience in a similar role in an API or medical device manufacturing company is preferred.
• Knowledge of the English language at B2 level.
• Problem solving skills and flexibility, as well as cooperation and teamwork.

Our offer

• One-year fixed-term initial contract.
• ‘C’ grading of chemical pharmaceutical national collective agreement.
• Salary between € 34.000 and € 35.000.
• Collective Bonus and company Welfare.

In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.

Fidia Farmaceutici promotes parity and inclusion in all its actions.

All people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age.

All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department.

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