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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