Corporate Quality Compliance Specialist

Responsabilities

• Compliance to pharmaceutical standards and to internal procedures,
• Regulatory compliance of operations (production and analytical documents and processes) to Chiesi Global MAs,
• Global Products lifecycle regulatory support (i.e. CMC documentation review, deficiency letter responses, documentation for first registration),
• Global Products lifecycle quality compliance activities (i.e. item codes attributes on SAP system, materials specifications on LIMS system),
• Support to lifecycle changes compliance assessment and to changes implementation phase,
• Bridging activities between manufacturing plants (internal and external) and Global Regulatory Affairs

Technical Skills

• Knowledge of applicable national and international legislation (EMA, FDA, ICH guidelines, etc.)
• Knowledge of reference pharmacopoeias monographs (EP, USP mainly).
• Knowledge of GMP and Quality Systems.
• Knowledge of regulatory framework and registration dossier of MAH.

Required experience

• Experience in manufacturing and/or analysis in pharmaceutical companies at least 2-3 years
• Experience in regulatory and/or quality positions.

Education

Degree in scientific disciplines (CTF, Chemistry, Biology, Industrial Chemistry, Pharmacy)

Languages

Fluent English (Written & Spoken)

Soft Skills

• Establish good and proficient interpersonal relationships 
• Ability to quickly get used to new, dynamic and multicultural working environments
• Attitude to problem solving and flexibility to find new solutions and alternative routes
• Organizational skills and time management skills
• Goal-oriented approach and respect of deadlines
• Ability to establish good professional collaborations with members of a work group, even under stressfull situations. 

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