QA Documentation Specialist

  • Salary: €25-30 per hour LTD/Umb rate
  • REF Number: 00046302
  • Consultant: Julie Marshall
  • Contact: 01438 723500
  • Date Published: 15.08.2019
  • Closed Date: 12.09.2019
  • Sector: Pharmaceutical
  • Location: Ireland (Cork area)
  • Discipline: Qa/Validation

CK Group are recruiting for a QA Specialist to support Packaging and Engineering Packaging to join a biopharmaceutical company at their site based in Carrigtwohill, near Cork on a 12 month contract basis. The rate of pay is up to €30 per hour.The Company:

Our client is a biopharmaceutical company that discovers, develops and commercialises innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Their Ireland operations are responsible for manufacturing, quality control, packaging, and the release and distribution of the company's products in the European Union and other international locations.

The Location:

This role will be based at our clients manufacturing site in Carrigtwohill. Carrigtwohill, officially Carrigtohill, is a town in County Cork, Ireland with a population of 5,080. It is 12 kilometres east of Cork city and can be accessed via the N25.

The Role:

The QA Documentation Specialist will support all administrative tasks in relation to the quality related systems.

Key Responsibilities:

  • Provides administrative support related to the following electronic systems:
  • LMS System - ComplianceWire
  • Document Control System - Veeva Vault
  • QS Management system - Trackwise
  • Maintains documentation manuals to ensure accuracy and current information.
  • Ensure the correct and timely input of training related documents into the LMS System - ComplianceWire.
  • Participates in training on issues affecting own area of work. Notifies manager of compliance questions and issues.
  • Provides additional support and assistance on tasks and projects as directed by management.
  • Provides cover for Site Induction training, System end-user training, as required, to Cork & Dublin sites.
  • Writes and revises SOPs and work instructions for continuous improvement of documentation systems.
  • Provides Level 1 support for all systems previously listed.
  • Participates in cross site teams as the a QA systems team representative - Attending associated meetings ensuring QA systems team are represented & concerns/ issues communicated, aiding in the identification of potential improvements and participating in discussions on issues/ queries on the associated systems/process.

Your Background:

  • Relevant system administration experience in Pharma, Med Device or Food sector.
  • Entry level knowledge of current Good Manufacturing Practices (GMPs).
  • Demonstrates technical experience on any of the following systems within the Pharma, Med Device or Food sector - Quality System Management systems, Learning Management System or Document Control systems.
  • Entry-level proficiency in Microsoft Office applications.
  • Ability to work effectively in a team environment.
  • Solid verbal, written, and interpersonal communication skills.
  • Ability to effectively communicate with cross-functional peers.- Demonstrates basic knowledge of organizing, filing, scanning of documents and records.

For more information or to apply for this position, please contact Julie on 01438 723500 or email Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46302 in all correspondence.

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