Quality Operations Specialist

Role : Quality Operations Specialist

Mandatory Requirements

• Graduated / post-graduate in Pharmacy / Medicine or Chemistry / Biotechnology
• 5 to 8 years minimum experience in Quality or Regulatory Affairs
• Experience obtained in pharmaceutical manufacturing sites (+3 years).
• Knowledge of stability regulations and its application to the industry
• Skilled in the usage of IT tools (for example : Quality Forward, Share / DrugTrack, eDMS), SAP.
• English speaker
• Good organizational skills, stress resistance, and flexibility
• Good Team player and good in decision-making
• Interpretation / Analytical data.
• Experience in the pharmaceutical / biotech industry with a good level of GxP know-how is a strong plus.
• Reactivity, autonomy with a sense of urgency and priorities.
• Open-mindedness and team spirit.

Position Location :

ROLE SPECIFICATIONS

Role : Quality Operations Specialist

Department : Scientific Affairs

Reports to : Quality & Compliance Manager

Company : Zentiva Italia S.r.l.

PURPOSE OF THE ROLE

Support the Quality Assurance and Compliance function of Zentiva Italia S.r.l. in order to ensure compliance with Zentiva Italia S.r.l. applicable requirements and Corporate Zentiva guidelines.

The role will be focused in leading a periodic review of products commercialized in Italy under the Zentiva Italia S.r.l. authorization.

Main Responsibilities

Other Responsibilities

QUALITY

Comply with the principles of cGxPs and Zentiva's Quality Standards in carrying out the activities of competence and regularly participate in the related training.

HSE

Comply with the principles communicated within the framework of the Zentiva ESMS Policy, specified in the Company's internal regulations for the purpose of compliance with Occupational Health and Safety regulations and the Environment and Safety Management System.

VIGILANCE

Report adverse events and any other safety information related to ZENTIVA medicines, medical devices, cosmetics, and dietary supplements online in the manner provided for in internal procedures.

COMPLIANCE

Observe the Company's rules and policies. Fully adhere to the principles set out in the Code of Ethics.

SUSTAINABILITY

Adhere to the ESG principles detailed as part of Zentiva's Sustainability Strategy, which is divided into 3 pillars : People, Partners, Planet.

Skills Required

Sap, share, Edms