Corporate Quality Compliance Specialist

Beschreibung:

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.

Note

This search is open also in the external market, thus you will be evaluated in comparison with the external candidates.

Please submit your application within 15 calendar days from the date of posting. After that, the search will be closed internally.

When applying, please remember to notify your HR by e-mail about your application.

Before applying, we invite you to carefully read the Job Posting guidelines and relevant FAQs available on C-People under the "Recruiting" section. 

If interested do not hesitate to submit your application, we can discuss and evaluate your specific requirements/needs

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