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Quality Assurance Specialist, Mayo



Mayo, Ireland 

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Job Description:

The Opportunity

Team Horizon has an immediate requirement for a Quality Assurance Specialist. This is an exciting role and will focus around supporting a business unit within a global pharmaceutical manufacturer, reporting into QA Manager. Based in the West of Ireland, this role may suit someone from a QC background or someone from a validation/project engineering background.

The Role

  • To provide the QA oversight for upgrade works on the facility to support the commercialization of product.
  • Review and approval of validation documentation for equipment and facility upgrades.
  • Review and approval of validation documentation for analytical method validation for drug substance and drug product test methods.
  • Knowledge of cross contamination controls and strategies to successfully obtain licensure a multiproduct biologic suite
  • Work as part of a cross functional team on a daily basis for the delivery of upgrade facility and equipment, working with engineering, operations and validations
  • Work as part of an external team including regulatory affairs, global pharmaceutical technology, PDQA for the commercialization of a new product.

The Person

  • Bachelor’s degree in a scientific related area required
  • Minimum 3 years’ experience in a quality discipline in Pharma/Medical Device Environment
  • Experience of working within a regulated environment
  • Demonstrated knowledge of quality standards and regulations for cross contamination controls, biologics products and process validation
  • Ability to use sound judgment to make effective decisions within appropriate timeframes
  • Prove to be self-directed, self-motivated and ability to prioritise competing priorities
  • Excellent Communication Skills
  • Experience of working as part of internal and external teams to deliver projects

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Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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