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Quality Assurance Specialist - Belgium  

Johnson & Johnson (company)


Posted on : 07 June 2017

Project Description

Company description:
  • Our company is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. 
  • Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
  • Our company is one of the most innovative pharmaceutical companies in the world. 
  • Our research and development center develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions

The QA Specialist will:
  • Act as a quality assurance representative within the Repack activity team;
  • Review and approve GMP documentation, including Batch records, related to repack activities of finished products to ensure that it is free of error, in compliance with GMP and SOP requirements and that material and printed components are of the correct quality and status prior use;
  • Create and Maintain repack activities data for tracking and trending purpose and prepare and provide to the delegate QP the repack information for the Quality Improvement Plan (QIP) meeting.
  • Sign the repackaging certificate and perform quality transaction in SAP for repacked products and release of the repacked material;
  • Coordinate and participate to the process improvement in collaboration with operation team;
  • Ensure that the repack activities are in lines with the company standards by performing Gap assessment and following the action plan.
  • Participate and follow the repack implementation in collaboration with operation team;

On addition to the repack responsibilities, the function holder will will :
  • Interface with other departments regarding documentation requirements.
  • write work instruction (WI) and procedure (SOP) through Docspace system
  • Investigate on internal and external complaints and events related to distribution activities (ex. Temperature excursions), warehouse activities (ex. damages).
  •  The investigations, including corrective and preventive actions and impact assessments of the products, need to be documented in the Trackwise deviations handling system.
  • Investigated on customer complaints related to distribution and repackaging activities. For each customer complaint a thorough investigation and root cause analysis needs to be performed. These investigations need to be documented in the Trackwise and PQMS complaint handling system.
  • Initiate and approve record in TrackWise (Event/Deviation, CAPA, Supplemental Investigation)
  • Will investigate and/ or approve on events,deviations and CAPAs related to distribution activities and repackaging activities. 
  • The investigations, including corrective and preventive actions and impact assessments of the products, need to be documented in the Trackwise deviations handling system.
  • Assist the site quality head in reviewing changes related to the activities in the EDC. These changes will be documented in the COC system. 
  • Follow up the customer returns and destruction. Products are investigated physically and impact assessment on quality and compliance is performed, before the products can be taken back into the saleable stock.
  • Take the batch disposition of customer returns
  • Prepare the products & documents to establish shipments under quarantine (before the release of the products)
  • Ensure the batch disposition by performing batch status alignment during transfer of the goods from manufacturing sites or TPM sites to EDC.
  • Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes.
  • Perform GMP/ GDP training
  • Actively contribute to build the quality team, to increase on efficiency, to solve problems, and improve quality.
  • Assist in the preparations of external and internal inspections related to overall quality and compliance.
  • Contribute to the continuous improvement: describe all own processes, establish implementation plans and propose actively solutions.
  • Work in close collaboration with Quality Representatives of company Supply Chain Organization and Quality Representatives of our company  Commercial Organization (Local Operating Companies).

  • Knowledge and understanding of pharmaceutical GMP/GDP requirements.
  • Life science degree or equivalent
  • Relavant GMP experience is an asset
  • Preferred : working experience with SAP, trackwise, EDMS
  • French and English
  • Specific know how of systems
  • Ability to handle multiple tasks concurrently and complete tasks in a timely manner
  • Effective organization skills
  • Computer literate with intermediate level of understanding of Microsoft Word, Excel, and Access
  • Effective interpersonal communication. Must have effective verbal and written communication skills

  • As an employee we consider you as our most valuable asset. We take your career seriously.
  • As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
  • Through e-university, on the job training, various projects and programs, we ensure your personal growth.
  • Our benefits make sure we care for you and your family now and in the future.