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FTC Assoc Documentation Analyst

AbbVieMayo

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.

Job Description

Ready to make a Worldwide impact? We OFFER that.

Ready to drive innovation? 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.


We are now recruiting a Fixed Term Associate Documentation Analyst to join our DCC (Document Control Centre) department which is a part of the QA group in Westport. The DCC group is responsible for the processing of all CORAL Documentation for the Westport site. The DCC Department must maintain compliance with local, regulatory and legislative requirements with regards to Safety, Housekeeping, GMP and support and comply with internal environmental health and safety requirements, procedures and policies. It achieves these functions by interaction with QA, EHS, Compliance and regulatory affairs to ensure all internal procedures reflect current requirements.

So let’s tell you a little more about this role…


Key Responsibilities:

  • You will control, distribute, maintain, update and obsolete SOPs, Controlled Forms, Project Documents and Manufacturing Records on CORAL.
  • You will initiate training on all SOPs using LMS/Compliancewire system.
  • Distribution of WWQA Documentation both internally and externally to vendors where relevant.
  • You will update and distribution of internal department documentation.
  • You will run CORAL and LMS reports relating to DCC and other departments as required.
  • You will carry our submission of CORAL Access requests for new and updated CORAL accounts.
  • You will maintain all current KPI metrics at or above targets.
  • You will ensure DCC is in compliance with all procedures at all times.
  • You will deal with Internal and External customer queries under the guidance of the department Supervisor.
  • You will perform Dry Running / Real Time Execution of OQ/PQ scripts where applicable.



Qualifications

Education:

You will have a minimum of leaving certificate qualification.


Technical Skills and Experience: Examples below

  • Proven track record in a quality discipline in the Pharma/Medical Device environment.
  • Microsoft Office Word and Excel is essential.
  • Clear understanding of working within a regulated environment
  • Excellent communication skills
  • Ability to use sound judgment to make effective decisions within appropriate timeframes.

So, does this all sound like the right role for you? Then come join Abbvie!


AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.




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.

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