Interim Quality Assurance Specialist
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Location
Warwickshire, England
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Sector:
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Job type:
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Salary:
£120 - £170 per day
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Contact:
Adam Dennison
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Contact email:
adam.dennison@1st-executive.com
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Salary high:
170
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Salary low:
120
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Job ref:
J12086_1543479291
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Published:
over 5 years ago
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Duration:
12 months
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Expiry date:
2018-12-29
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Startdate:
ASAP
- Interim Quality Assurance Specialist - £120-170p/d
- Warwickshire
An Interim Quality Assurance Specialist at £120-170p/d is required for a unique specialist manufacturing organisation who are the world leaders in their field, and a rapidly expanding FTSE100 organisation. A 12 month initial contract in Warwickshire, likely to extend, and providing long term stability, this is an exciting opportunity within Quality Assurance and Regulatory Affairs for a candidate who is looking to develop their experience within a global, diverse and fast-paced function, and a world leading brand.
Role:
This Quality Assurance position is responsible for representing the function for all Field Safety Corrective Actions.
- Complete and/or manage Competent Authority reporting activities
- Act as single point of contact with the UK & Ireland Competent Authorities
- Collate and report evidence of FSCA closure for each affected country within EUCAN region.
- Direct non-standard questions to the relevant functions/teams
- Manage Competent Authority expectations and ensure timeliness of responses
- Develop and assist in product registrations & re-registrations, including the supply of necessary documents for Europe and Canada and to existing approved countries for our products.
- Managing and obtaining legalization of documents for our customers.
- Assist in the development, review and implementing regional policies and procedures based on corporate requirements.
- Assist in regulatory aspects of commercial business relationships to ensure compliance
- Assess commercial activities in the EU for compliance and propose and implement potential solutions.
Required Skills:
- Minimum 1-2 years experiences in regulatory affairs or quality assurance
- Minimum 3 years Quality Assurance activities related to medical devices or pharmaceuticals
- Proficient in Word and Excel, and good writing skill is needed. Experience in MS Access, MS Visio, Agile, and SAP desirable.