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Quality

Quality Assurance Specialist

  • Título Quality Assurance Specialist
  • Função Quality
  • Sub função Quality Assurance
  • Categoria Experienced Analyst, Quality Assurance (P5)
  • Local Cork, Ireland
  • Postado
  • ID obrigatória 2406183820W
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Descrição

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at  https://www.jnj.com/.  

Main responsibility:

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Pharmaceutical Sciences as required by GMP.  These activities include incoming materials release, batch review and release, nonconformance investigation, change control, documentation management, validation compliance activities etc.

Duties and responsibilities:

·      Responsible for executing tasks related to the management of batch records and release processes.

·      Responsible for performing tasks related to the completion of nonconformance investigations and site change controls.

·      Responsible for supporting and participating in audit activities (HPRA, JJRC, PRC, Customer etc).

·      Provides support and direction to all Departments to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behaviour model.

·      Partners with other departments to ensure that GMP compliance systems are implemented and aligned with JSC Quality Policies, Guidelines, Programs and Systems.

 

Qualificações

Essential qualifications

·      Bachelors degree required in a scientific or engineering discipline.

·      A minimum of 2 years experience in a quality, manufacturing, validation or compliance role within the pharmaceutical industry.

·      Experience & Knowledge of FDA/HPRA / EMEA regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

·      Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, HPRA, EMEA and other authorities.

Desirable

·      Advanced degree in a scientific or engineering discipline.

·      Qualified Person (as qualified).

Key competencies required

·      Excellent interpersonal skills.

·      Quality management skills: problem solving, statistical thinking, continuous improvement, etc.

·      Relationship skills: negotiation skills, presentation skills, listening skills, collaboration & teamwork.

·      Time management skills.

·      Attention to detail without losing sight of the big picture.

·      Results and performance driven.

·      Adaptable and flexible

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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