Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Fixed Term Contract
Contact Shane Connolly
email contracting@hero.ie

Quality Assurance Specialist

Job ID: JOB-11481
Quality Assurance Specialist

My client a leading medical device company in Galway is looking to hire a Quality Assurance Specialist to join the team on a 12 months contract, a maternity leave cover.


Purpose


Provide Independent Quality Assurance Support to the Operations Analytical laboratory. Maintains, develops and implements laboratory methodologies, systems and practices. Provide independent guidance to te analytical lab while ensuring compliance to procedure and cGMP requirements.

Responsibilities:

  • Provides quality assurance support and direction to the analytical laboratory responsible for the testing and release of all drug combination products and raw materials used on the site.
  • Responsible for ensuring that Raw Materials, Finished Goods, non-routine and Stability testing is carried out in accordance with cGMP both in the site laboratories and at the contract laboratories.
  • The QA Specialist shall provide support and guidance in the areas of cGMP, Compliance, Regulatory, and Technical Investigation.
  • The role also requires working with the cross functional groups including Product Release, Supply Chain Planning, Shipping and Distribution groups.
  • Preparation and compilation of Annual Product review 
  • Schedule and Complete laboratory assessments
  • Provide the independent review of NCEP’s and eCAPA
  • Review and approval of equipment/ software testing method validation

Education/Qualifications & Experience:

  • NFQ Level 8 Qualification (240 credits) in science or related engineering discipline. Minimum of 3-5years in a similar role.
  • Experience working in the pharmaceutical or biotechnology industry is essential.
  • Excellent written and verbal communication skills.
  • Experience working with dynamic cross functional teams and prove abilities in decision making.
  • Strong organisational skills including ability to follow assignments through to completion.
  • Detailed knowledge of applicable regulatory requirements.
  • LIMS/SAP/Empower while not necessary is an advantage

For further information on this role please contact Shane Connolly on 0872197421 or contracting@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ 



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Shane Connolly

JOB-11481

Quality Assurance Specialist

Shane Connolly

Role Type Fixed Term Contract
Contact Shane Connolly
email contracting@hero.ie
mobile +353 87 219 74 21
linkedIn profile click here

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