QA Specialist

Job description

What you will do;

  • The QA specialist will be responsible for managing deviations by participating in investigations, carrying out root cause analysis as well as implementing CAPAs.
  • Investigate/ evaluate issues raised by customers.
  • Responsible for change controls by evaluating possible outcome as well as regulatory impact of product/ patient.
  • Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
  • Generate procedures, documents/ records, technical support documentation, Quality Product Quality Reviews and QMS SOPs.
  • Support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors and providing oversight as required.
  • Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
  • Participate and follow-up in third party audits and/or inspections carried out at the site by the authorities or clients.
  • Complete all required QMS assignments (CAPAs, investigations, actions etc) in accordance with timelines.
  • Assist in preparation for and attendance at Regulatory Audits.

What you will have;

The QA specialist will have a relevant degree and 4 years expereince with pharmaceutical finished products.

Experience with deviation management and HPRAs is needed.

Why you should apply;

Benefits include pension and 23 days annual leave 

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