Specialist QA Pharma Complaints.

☞ Johnson & Johnson

View: 220

Update day: 25-04-2024

Location: Schaffhausen Schaffhausen SH

Category: Quality Assurance / Quality Control

Industry: Medical Equipment Manufacturing Hospitals Health Care Pharmaceutical Manufacturing

Job type: Full-time

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Job content

‘Caring for the world, one person at a time ‘… inspires and unite the people of Johnson & Johnson, we embrace research and science- bringing innovative ideas, products and services to advance the health and well-being of people.

Janssen Pharmaceutical is part of Johnson & Johnson and responsible for bringing innovative medicines towards patients throughout the world.

The QA Pharma Complaint Specialist performs quality activities in support of new and established products. The position has a great deal of interaction with many internal departments, including Engineering, Manufacturing, Purchase, Quality Control, and global Partners. The QA Pharma Complaint Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements; such as maintain processes to ensure high quality products and compliance with current standards; documentation reviews; support quality audits; and data analysis

QA Pharma Complaint Specialist

Specific Responsibilities
  • Review, analyze, coordinate and/or investigate assigned customer complaints; consisting in accurate documentation, inspection of product returns, investigation of technical details, root cause analysis, risk assessment, and assist in associated CAPA investigations
  • Ensure accurate documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications.
  • Develop a detailed understanding of the complaint database, and products in scope of the site.
  • Assess of market impact of a complaint and raise critical issues for proper disposition as necessary.
  • Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action.
  • Support internal, external, and third-party audits.
  • Support additional project team activities and/or investigations, and participate in process improvement activities and projects

Qualifications

Required skills and experience
  • A Bachelor’s Degree in engineering, physical, biological, natural sciences or another related field is required.
  • A minimum of 1 year of experience in quality in a pharma/medical device or other regulated industry is required. (Previous experience with complaints handling is preferred)
  • Investigative & analytical critical thinking skills.
  • CAPA root cause investigation execution, implementation of corrective and preventive actions to improve quality processes.
  • Strong decision-making skills - able to make sound business decisions with sometimes limited information.
  • Effectively manages work & time to produce desired outcomes (time management).
  • Continuous interaction with global groups and the ability to collaborate with global customers is required.
  • Strong written and verbal communication skills in English

Desirable to have knowledge of statistical applications and auditing practices

Primary Location

Switzerland-Schaffhausen-Schaffhausen-

Organization

Cilag AG (8562)

Job Function

Quality

Requisition ID

2206003302W

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Deadline: 09-06-2024

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