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Vacancy Details

Quality

QA Specialist - Cork

Contract Type: Contract
Sector:
Location: Cork
Date: 16/08/2017
Job Reference: 88606

Job Description

Contact: Jenny Dore
Email: jenny@hero.ie
Telephone: 0212066287


QA Specialist
Our client, a medical device company in Cork are currently looking to recruit a QA Specialist for their site on a contract basis.


What will I be doing
  • This position is responsible for carrying out tasks and projects related to management of Quality Assurance as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities.
  • Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
  • Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the company's Standard of Leadership behaviour model.
  • Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
  • Batch Record Review & material release to ensure compliance with GMP requirements.
  • Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
  • Carries out tasks related to the management of batch records design and approval.
  • Carries out administration of the SAP Quality Management Module.
  • Carries out tasks relating to the management of site change control systems.
  • Compiles Annual Product Reviews.
  • Supports all validation activities on site as described in the Site Validation Master Plan.
  • Approves and compiles where appropriate validation protocols and reports.
  • Supports system qualification and process validation activities.
  • Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
  • Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
  • Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
  • Perform GMP audits on-site and vendor facilities as required.
  • Carries out tasks related to the administration of site supplier approval process.


What do I need
  • Bachelor's Degree in a scientific/technical discipline
  • 3 years + experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
  • Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
  • Experience in auditing of external suppliers, contractors and vendors.

For further information on this QA Specialist role in Cork please contact Jenny Dore on 0212066287 / jenny@hero.ie
Check out all our open jobs on our HERO Recruitment website - www.hero.ie

Please Note: HERO Recruitment will not forward your details to any company without your prior approval


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“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

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