Gcp Quality Specialist

hace 2 semanas

Buenos Aires, Argentina Johnson & Johnson A tiempo completo

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.

_

  • Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. _
  • When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. _
  • At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.
We focus on areas of medicine where we can make the biggest difference:
Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. _

  • We are Janssen. _
  • Our mission drives us. _
  • Our patients inspire us. _
  • We collaborate with the world for the health of everyone in it. _

We are searching the best talent for GCP Quality Specialist to be in Buenos Aires, Argentina.

Purpose:

The Local Compliance Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.


Principal Responsibilities:

  • Quality and Compliance Oversight Activities
  • Monitor compliance risk and ensure mitigation/remediation actions are defined
  • Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are
addressed in a timely manner.

More specifically perform the following riskbased activities:

  • Conduct On-Site Compliance Monitoring Visits
  • Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S Integrated Quality Plan for the trial
  • Planning and execution of local QC checks
  • Support and advise local and central study teams in root cause analysis of significant observations
  • Ensure appropriate filing of the QC reports
  • Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals
  • Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed
  • Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions
  • Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents
  • Local Onboarding and Consultation
  • Support onboarding of new hires
  • Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc
  • Provide advice regarding SOP, system and GCP questions of moderate complexity
  • Supports managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk


 Local regulatory intelligence
  • Perform impact assessments of new/revised local regulations, guidance and standards
  • Support central functions in ensuring local intelligence is up to date (e.g., RIACS, T-Race, IRON)
Collaboration with Business Quality- Support LOC Management Review in collaboration with LOC Business Quality partners

  • Support local supplier assessments as appropriate
  • Support annual Due Diligence update, certification and training of local suppliers, if applicable

Qualifications:

Education and Experience Requirements:

Education:

A minimum of a Bachelor's Degree in Science (BSc) or Arts (BA) or 4-6 years relevant experience equivalent is required.

A minimum of 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP
experience within clinical research and development and/or quality assurance.

Related Experience:

  • Knowledge of the overall drug development process
  • Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
  • Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
  • Ability to translate data into informat

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