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Title

QA Specialist

Salary/Rate
€16 - €20/hour
Location
Cork, County Cork
Posted
12/08/2019 - Expiring soon!
Agency
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Description

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities. Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.

Duties

  • Batch Record Review & material release to ensure compliance with GMP requirements.
  • Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
  • Carries out tasks related to the management of batch records design and approval.
  • Carries out administration of the SAP Quality Management Module.
  • Carries out tasks relating to the management of site change control systems.
  • Compiles Annual Product Reviews.
  • Supports all validation activities on site as described in the Site Validation Master Plan.
  • Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
  • Supports system qualification and process validation activities.
  • Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
  • Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
  • Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
  • Perform GMP audits on-site and vendor facilities as required.
  • Carries out tasks related to the administration of site supplier approval process.

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the usual way. Elevate will send you an email, please open, click and action that email as soon as possible. Once the application process is completed within Elevate, your application will then visible to the hiring recruiter. If you don't complete the process in Elevate you will not be visible to the recruiter or hiring manager.

If you have any problems at all with the process you can contact the Elevate support team at any time on (see below)

Type
Contract
Start Date
ASAP  
Contract Length
12 Months  
Job Reference
CVL-GC-6803-120819
Job ID
210592112
Applications
Less than 10
 
 

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