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Quality Specialist - Pharma Solutions - SME sized business

Job Seekers Ireland Engineering, Science Manufacturing, Pharmaceutical

Job Summary

  • Limerick
  • Permanent
  • BBBH804133
  • Apr 01, 2022
  • Competitive
Job Description

This is an excellent opportunity to join a rapidly expanding business where your voice will be heard and you will have direct access to Senior Management

I am delighted to work with a rapidly growing Pharma solutions business who are based in Limerick and are looking for a Quality Specialist to join them on a Permanent basis.

This individual will join a tight knit quality team and will help to support all Quality activities on site. This team are responsible for maintaining the product specifications & COA's, raw material release, work order release, and other duties as required.

Key responsibilities:

  • Prepare, verify & release of specifications and certificate of analysis;
  • Pre-approve raw material COAs;
  • Review & release of raw material, product and packaging materials;
  • Help investigate quality complaints.
  • Suggest improvements to SOPs.
  • Coordinate with Quality Control for testing
  • Establishing a system to release or reject raw materials, intermediates, packaging and labelling materials
  • Documentation review
  • Ensuring that nonconforming products and critical deviations are investigated and resolved in a timely manner
  • Reviewing and closing out of specification / out of trending investigations;
  • Perform internal audits
  • Qualification of suppliers for critical raw materials and packaging components
  • Qualification of external service providers
  • Reviewing and approving validation protocols and reports and supporting validation activities across the business
  • Ensuring that quality-related complaints are investigated and resolved in a timely manner

Experience & Educational Requirements:

  • Bachelor Degree or equivalent in Chemistry or a related science
  • 3 years+ of Quality Assurance Experience or equivalent, ideally in a Pharma environment
  • Technical writing ability
  • Knowledge of major Pharmacopoeial compendia
  • Knowledge of GMP, ICH and ISO guidelines
  • Strong team member and Communicator

If you are interested in this role, or if you would like to find out more information then reach out to Kellie O'Donovan today on 021 2300 412 or kodonovan@morganmckinley.com

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

kellie-o-donovan
Kellie O'Donovan
  • Principal Consultant | Engineering Recruitment - Quality & Validation
  • 353 (0) 21 2300300
  • kodonovan@morganmckinley.com