Post a job
Quality Technical Specialist

Company:
PE Global
Location:
Cork, Country: Ireland
Job Type:
Job Description

PE Global are currently recruiting for a Qutality Tech Specialist for a client site in Cork:

Purpose of Role:

Quality Technical Specialist Position:

Our client are hiring a Technical Specialist within the Lab Operations Technical IPT. This position requires someone with strong technical knowledge and experience in Chemistry/Raw Material analytical methods with multidisciplinary expertise to provide technical support to the commercial testing laboratories.

The Technical Specialist will provide technical expertise and coaching to the Quality Laboratories for routine technical support and investigations.

The Technical Specialist is accountable for the effective and efficient running of projects within cross-functional multi-skilled teamwork environment, collaborating effectively with stakeholders.


Primary activities/responsibilities:

  • Good knowledge of protein chemistry analytical and compendial methods
  • Abreast with EU/US regulations for analytical and compendia methods within in GMP environment.
  • Provide technical expertise and coaching to support lab operations.
  • Lead the delivery and of projects whilst adhering to project timelines through the use of project management tools.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, in accordance with GDP (good documentation practice) and site procedures.
  • Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other Sites and contract laboratories as required.
  • Lead continuous improvement initiatives to drive efficiencies within the department.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.


Qualifications, Skills & Experience Required -

Qualifications and Experience:

  • Degree or 3rd level qualification (Science, Engineering, Quality). Masters preferred.
  • Knowledge of protein chemistry and analytical and compendial methods.
  • Desired Qualifications/Experience:
  • D./M.Sc. qualification (Science)
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Project management qualification such as Project Management Professional etc.

THE COMPANY

As a company we are committed to ‘Inventing for Life’ in all that we do. Our client keep the patient at the very heart of all that they do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.


Interested candidates should send their CV to audrey.mccarthy@peglobal.net or call 0214297900

Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: PE Global
Company size: 1-49
Contact: NA