Ass. Spclst, Quality Assurance

2 settimane fa

Roma, Italia MSD A tempo pieno

**Job Description**:
This position reports to the Associate Director, In-Market Quality Country Lead.

The following core responsibilities are generally applicable to the In-Market Quality Assurance Associate Specialist role:

- Under local Quality Responsible Person (QRP) responsibility, contributes to ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good Distribution Practice) are fulfilled (where applicable as per the country distribution model)
- Where applicable, support the adherence to our Manufacturing Division Quality Manual
- Supports the implementation and maintenance at our organization Italy offices of a quality system as pertains the activities in scope, tailored on the local regulatory requirements, organization and activities; integration of this part in the local office QMS
- Supports the development and maintenance of local Quality training program as pertains the activities in scope, including assessment of training effectiveness
- Contributes to ensure Quality perspective is brought into local business initiatives with Quality impact
- Supports QRP and IMQ team during batch recalls
- Supports DPOC in management of communication with customers as regards product information and stability
- Deviation management, overview and tracking; management of CAPAs, change controls
- Support the handling of temperature excursions during transportation, warehousing and distribution
- Support the IMQ oversight on repackaging/re-stickering activities performed by the appointed 3rd party logistics (3PL) provider
- Support the management of returned goods
- Support the process of importation of non-registered product in country
- Support the IMQ team in self-inspections
- Supports, when requested, the correct management of traceability topics (MoH tracking System, IPZS Bollini stickers and serialization preparation activities) and Countefiet Diversion Tampering events (thefts included)

**Requirements**:

- Bachelor's Degree or higher in Chemistry, CTF, Pharmacy, Biology, Science or related discipline.
- Minimum of 1 year experience in the pharmaceutical industry, with solid quality and compliance experience. Must have expertise and experience in Quality Systems and Quality Assurance (GMP and GDP contest), including knowledge of EU and italian regulatory requirements.
- Organizations skills.
- Strong demonstrated interpersonal, communication (both verbally and in writing), collaborative and leadership skills
- Complete fluency in English and Italian.
- Strong interpersonal skills to communicate, collaborate and influence
- Ability to think End-to-End when analysing problems and resolving project conflicts
- Willingness to be flexible and to work in a rapidly changing environment

As part of the role, the incumbent will have:

- Interaction with local business and regional Quality Management establishing and maintaining strong partnerships with local and regional functional groups that impact EMEA Quality and Compliance.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R249260

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