Regional Quality Oversight Specialist Lazio

Regional Quality Oversight Specialist
Roma
Lazio, Lazio

Essential functions include, but are not limited to**:

In cooperation with the Regional Quality Oversight Lead ensures that all our Company's products at UPS Hungary are stored and distributed in accordance with our Company Quality Requirements and all applicable regulatory requirements to meet both internal and external customer demands, the Product License, GDPs, contractual and Quality Agreements obligations.

Ensures monitoring of the quality performance of UPS Hungary through direct QA oversight and a detailed KPIs system, support, and technical advice to ensure permanent audit readiness.

Works in close cooperation with the QPs and QRPs to ensure the quality performance of the local external partners working in the perimeter of the Regional Oversight.

This also includes providing support to build effective quality systems at the partners and supporting continuous improvement activities.

The External QA oversight of regional UPS Hungary is mainly a remote work though for cause and routine visits are scheduled to discuss business performance and issues.

Day-to-day activities include counselling to the partners' site leadership; on-site supervision as required; coaching and training; a wide range of COMET transactions; analysis of KPIs; review of logistics and distribution complaints and investigations; re-packaging in GMP conditions; resolution of quality issues; participation in audits; etc.

Primary Activities

Reports to the Regional Quality Oversight Lead, for instructions and steps concerning Quality Operations.

Support Regional Quality Oversight Lead on his daily workload for Oversight, back-up of the Regional Quality Oversight Lead.

Responsible for leading the restricted weekly quality meeting (our Company UPS RPs, our Company Regional Supply Chain and our Company Quality Oversight)

Coordinate/align with our company UPS RPs and UPS Quality.

Support the weekly meeting conduction.

Review Quality KPIs on UPS Hungary processes (GDP/GMP) and raise eventual gaps against the KPIs objectives defined.

Ensures appropriate investigations are conducted by UPS Hungary/external partners into abnormal occurrences such as product damage, inventory rejections, atypical events, customer complaints, our Company QRPs claim, temperature excursions, claims raised in UPS repackaging activities etc.

Coordinates support from appropriate staff groups and recommends corrective measures; assists in the coordination of significant investigations including Fact Findings and the coordination of product recalls as needed.

Support, review and trace warehousing/transportation investigations and related CAPAs.

Monitor the UPS follow up on the CAPA agreed

Assesses Temperature Excursions reported by recipients of the UPS Hungary/external partners under his/her oversight and propose product disposition recommendations.

Submitting proposals for organizational and technical measures to remedy the identified defects;

Cooperates closely with our Company Regional Supply Chain and our Company Release and Shipping Sites.

Skills required

Degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, or Engineering.

Fluent in English.

Must have experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GDP/GMP, regulatory requirements and good documentation practices.

Must demonstrate the prerequisites to fulfil their duties

Critical Leadership Behaviours

Persuasiveness

Determination

Good communication skills

Team spirit

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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace