In-Market Quality Specialist Lazio

In-Market Quality Specialist
Roma
Lazio, Lazio

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 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, ensures adherence to our Manufacturing Division Quality Manual and provide feedback to our Manufacturing Division Quality Manual Chapter owners.

- Supports the implementation and maintenance at our Company 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

- Supports QRP with Health Authority (HA) interactions and notifications regarding Quality and Supply issues

- Contributes to ensure Quality perspective is brought into local business initiatives with Quality impact

- Supports QRP in local coordination and execution of batch recalls

- Has the Quality oversight on management of relevant customer complaints and supports DPOC in management of communication with customers as regards product information and stability

- Deviation management, overview and tracking; management of CAPAs, change controls

- Handling of temperature excursions during transportation, warehousing and distribution

- Oversight of repackaging/re-stickering activities performed by the appointed 3rd party logistics (3PL) provider

- Management of returned goods

- Pharmaceutical Evaluation of Tenders

- Participates in the process of importation of non-registered product in country

- Ensures that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place

- Supports due diligence and audits to assess competence and reliability of external partner(s) and Quality oversight of subcontractors and Third Party Logistics providers (3PLs) to ensure operations (e. g.

incoming inspection of our Company products, storage, picking, packing and distribution) comply with regulatory requirements and the conditions specified in the Dossier and in the Quality Agreement.

- 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)

**Qualifications**:

- Bachelor's Degree or higher in Chemistry, CTF, Pharmacy, Biology, Science or related discipline.

- Minimum of 2 years' 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.

- Project management and organizations skills.

- Strong demonstrated interpersonal, communication (both verbally and in writing), collaborative and leadership skills

- Complete fluency in English and Italian.

- Strong interpersonal and leadership 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

**Who we are

We are known as Merck & Co. , Inc. , Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.

Here, you have that opportunity.

You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

**Search Firm Representatives Please Read Carefully

**Employee Status**:

Regular

**Relocation**:

No relocation

**VISA Sponsorship**:

**Travel Requirements**:

**Flexible Work Arrangements**:

**Shift**:

**Valid Driving License**:

**Hazardous Material(s)**:

**Number of Openings**:

1

**Requisition ID