Qualified Person

작업 내용

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Want to be recognized for your leadership? We offer that

Ready to lead a high performing, diverse team? We offer that too

Welcome to AbbVie!

At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that’s felt within healthcare and beyond.

Odyssea Pharma is a pharmaceutical production and our success is based on the commitment of our teams on the site and around the world. Odyssea Pharma sprl is one of the Abbvie Group’s centers of excellence for women’s health, offering the GMP manufacturing of the Levosert ™ hormonal intrauterine device and a quality and regulatory expertise from a dedicated site located in Liège (Grace-Hollogne), in Belgium.

We are currently recruiting a Qualify Person to be part of our Quality team in our Liège site, Odyssea Pharma, in Belgium, reporting directly to the Head of Quality.

Does this role entice you? Then read on for some of the day-to-day responsibilities:

You will

• Ensure that finished goods releases finished are made efficiently, on time and in compliance with regulatory requirements
• Issuing certificates of conformity
• Support the implementation and maintenance of the QMS in line with corporate and regulatory requirements
• Supervise all GxP processes applicable to the Odyssea site
• Ensure the resolution of quality events (deviations, OOS...) and facilitate the implementation of CAPA
• Act as a quality representative during inspections and audits
• Participate actively in the internal audit program
• Actively participate in process simplification and continuous improvement efforts
• Support the RA requests from Marketing Authorization Holders
• Manage documentation related to activities above, including the alignment between RA files from MAHs and local specifications/instructions as well as the data integrity dimension
  

Qualifications

Want to be recognized for your leadership? We offer that

Ready to lead a high performing, diverse team? We offer that too

Welcome to AbbVie!

At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that’s felt within healthcare and beyond.

Odyssea Pharma is a pharmaceutical production and our success is based on the commitment of our teams on the site and around the world. Odyssea Pharma sprl is one of the Abbvie Group’s centers of excellence for women’s health, offering the GMP manufacturing of the Levosert ™ hormonal intrauterine device and a quality and regulatory expertise from a dedicated site located in Liège (Grace-Hollogne), in Belgium.

We are currently recruiting a Qualify Person to be part of our Quality team in our Liège site, Odyssea Pharma, in Belgium, reporting directly to the Head of Quality.

Does this role entice you? Then read on for some of the day-to-day responsibilities:

You will

• Ensure that finished goods releases finished are made efficiently, on time and in compliance with regulatory requirements
• Issuing certificates of conformity
• Support the implementation and maintenance of the QMS in line with corporate and regulatory requirements
• Supervise all GxP processes applicable to the Odyssea site
• Ensure the resolution of quality events (deviations, OOS...) and facilitate the implementation of CAPA
• Act as a quality representative during inspections and audits
• Participate actively in the internal audit program
• Actively participate in process simplification and continuous improvement efforts
• Support the RA requests from Marketing Authorization Holders
• Manage documentation related to activities above, including the alignment between RA files from MAHs and local specifications/instructions as well as the data integrity dimension
  

Travel

No

Job Type

Experienced

Schedule

Full-time

Job Level Code

IC

Equal Employment Opportunity

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.