Quality System and Operational Support

Job description

·  Categoria professionale
Scientifico / Farmaceutico - Scientific Officer & Regulatory Affairs
·  Località
Milano, Milano
·  Data inizio
23/09/2019
·  Riferimento esterno
QUALITYSYSTEMANDOPERATIONALSUPPORT-0660-2616

Adecco Medical&Science ricerca per importante azienda farmaceutica

Un/a Quality System and Operational Support

Main Responsibilities
- Execution of the regulatory portion of the change control process in Product Dossier Management system ( PDM) and QTS (Trackwise) for product change controls initiated by contractors or impacting COQA managed contractors.
- Provides regulatory support to successfully conclude responses to deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
- Serves as the main point of contact for PIH or PEH RA organization or Local Regulatory Affairs in the Country Offices (for Single market/Regional products) for coordinating supporting documentation and filing strategies associated with Regulatory submissions for COQA managed Drug Products.
- Participates to Virtual Site Operating Teams as the Regulatory expert for the products supplied by the contractors and if required to participate to Site Quality visits at the contractors.
- Managing routine Customer Quality complaints for commercial Drug Products in PCOM and interactions with the Contractor Quality organization for ensuring that the investigation reports are appropriate and acceptable.

Qualifications
- BA/BS Science, Engineering, Pharmaceutical sciences or related technical discipline
- Minimally 3 years in a GXP setting and/or Regulatory Affairs role
- Advanced computer skills of MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise.
- Command of English language required and multi-lingual is beneficial.
- Strong verbal and written communication including presentation skills
- Shows strong negotiation skills and customer focus
- Is diplomatic in communication with internal and external customers
- Demonstrates ability to prioritize work, to act and work independently and to report items as required to Team leader
- Takes initiative and is proactive
- Able to manage multiple projects
- experience in API manufacturing/quality/regulatory will be especially taken in account

Fixed-term employment contract 6 months
Location: Milano

Disponibilità oraria: Full Time

Patente: B