15 ott - Firenze
Menarini
Questa posizione è in Menarini Il processo di selezione sarà interamente gestito Menarini.
-- Overview We are seeking a highly organized and detail-oriented Site Regulatory Compliance Associate to join our team.
The role is involved in the operational and regulatory document management of the Quality Assurance Department.
Involvement in "Global" projects is also possible.
He /she will report to the Change and Supplier Manager.
Main Activities drafting and reviewing documentation related to the company Quality System.
Job Requirements Education: Degree in technical/scientific disciplines (preferably CTF/Pharmaceutical Chemistry and Technology, Pharmacy, or Chemistry).
Languages: Fluent written and spoken English.
Experience: Experience in the regulatory sector of pharmaceutical manufacturing (at least 3 years); knowledge of main AIFA procedures and practices.
Eligibility to act as a Qualified Person.
Soft Skills:
Excellent interpersonal and communication skills to interface effectively with various internal (Production, QA, Global, Regulatory Affairs) and external stakeholders.
Strong motivation, proactivity, precision, problem-solving attitude, strong goal-orientation, and a "lean" approach.
Leadership skills and assertiveness, with a determined and dynamic character.
Good relationship skills, flexibility, and willingness to travel.
Strong sensitivity to quality KPIs and continuous improvement topics.
Planning and organizational skills.
Proficiency in using spreadsheet and statistical processing software The selected candidate will be employed under Category C in accordance with the provisions of the current National Collective Bargaining Agreement (CCNL) for the Chemical and Pharmaceutical Industry, including all applicable contractual and remuneration terms, and in compliance with Legislative Decree No. *******.
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