Accessability Links
Cookies on our website
By continuing to use this website we will assume you are happy to receive cookies as outlined in our cookie policy
Accept Policy

QA Specialist



Location:
Cork
Salary:
Negotiable
Sector:
Pharma & Life Sciences, Quality & Regulatory
    Apply via LinkedIn
This vacancy has now expired.

Our client, a Pharmaceutical company is currently recruiting a QA Specialist for a 12-month contract in Cork.

QA Specialist

Position Summary:


This position is primarily responsible for the wholesale distribution activities of the site and ensuring Good Distribution Practice (GDP) guidelines are adhered to always. The candidate will also be responsible for carrying out tasks and projects related to management of Quality Assurance activities at JSCI as required by Good Manufacturing Practice (GMP). These activities include change control, non-conformance investigation, supplier qualification, incoming materials release, batch release, annual product review and validation compliance activities at JSCI.


Responsibilities:

  • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation related to J&J projects as required by Good Manufacturing Practice (GMP).
  • These activities include review and approval of change controls, non-conformance investigations, and protocols. Primary Tasks and Responsibilities.
  • 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 J&J Standard of Leadership behaviour model.
  • Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
  • Supports the management of GMP compliance systems through the following activities:
  • Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
  • Carries out tasks related to the administration of project and site non-conformance management systems:
  • Reviews and/or approves non-conformance investigations and their associated documentation.
  • Manages entry of non-conformance records into the appropriate electronic system.
  • Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
  • Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
  • Approves closure of non-conformance investigations on completion of the investigation and associated corrective actions.
  • Carries out tasks related to the management of project and site change control systems:
  • Reviews and/or approves change control requests, implementation actions, and request closures.
  • Manages entry of change control records into the appropriate electronic system.


Qualifications and Experience:

ESSENTIAL:

  • Bachelors Degree in a scientific/technical discipline required
  • A minimum of 2 year's experience in a quality, manufacturing, validation or compliance role within the biological and/or pharmaceutical industry.
  • Experience in Good Distribution Practice regulations, working as a Responsible Person or a Deputy Responsible Person
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologic and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

DESIRABLE:

  • Experience in development/ and or evolution of GMP systems.
  • Operational experience.
  • Experience in leading a project or team
  • Experience in auditing of external suppliers, contractors and vendors.


Berkley Engineering is a specialist recruitment consultancy, which recruits pharmaceutical, medical device and clinical professionals throughout Ireland & Europe. For more information and to see all the Engineering Jobs available go to http://www.berkley-group.com

To apply: If you would like to discuss this vacancy further or to discuss your career and other job options in confidence, please telephone Tim McCarthy on +353 (0)21 4289609 or send your CV to tmccarthy@berkley-group.com

Our story in two minutes

At Berkley Group, we approach resourcing and recruitment in a way that’s distinctly insightful and personal. We have outstanding knowledge in our four specialist areas: IT, Pharmaceutical & Life Sciences, Engineering and Search & Selection. But as you’ll discover, it’s how we apply this knowledge that makes us different.

Our expertise spans the globe, so we can reach further for the right solutions. And we’re able to deal with a broad range of challenges because we are growing providers of talent management, business solutions and recruitment.

Have more time? Learn more