Senior QC Specialist

  • Dublin
  • Contract 12 months
  • JO-1812-64092_1548072163

Summary

Responsibilities

  • QC Representative for site / laboratory upgrade projects
  • Plan and manage QC related activities from site projects.
  • Manage all sample management activities related to NPI activities throughout the site
  • Sample shipments and temperature monitoring activities for NPI activities
  • Create/own and approve protocols, sample plans, SOP and documentation related to NPI
  • Authoring, executing and documenting the qualification of existing laboratory equipment in a cGMP regulated environment.
  • Writing equipment validation protocols and associated summary reports.
  • Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
  • Initiate and/or implement changes in controlled documents.
  • Write protocols and perform assay validation and equipment qualification/ verification.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • May conduct lab investigations if necessary.
  • Evaluate lab practices for compliance on a continuous basis.
  • Create APPX data files and randomisation memo to facilitate data analysis.
  • LIMS data coordination of commercial and import testing on site where applicable
  • May provide technical guidance.
  • Contribute to regulatory filings.
  • Escalate issues professionally and on a timely basis
  • Auditing documentation and operation process
  • Take initiative to identify and drive improvements
  • Ability to manage multiple assignments and processes



Requirements:

  • Broad technical knowledge within QC
  • Bachelor's degree in a Science related field is required
  • 8+ years of biopharmaceutical QC experience or related QC or GMP laboratory experience in the pharmaceutical or medical device industry.
  • Experience with regulatory compliance in cGMP
  • Experience with project management
  • Experience in equipment validation
  • Auditing documentation and operation process
  • Recognizes and understands the cross-dependencies of the technologies and understands the impacts on the organization
  • Familiarity with change management approaches, tools, and methodology
  • Strong facilitation skills and presentation skills
  • Ability to work and collaborate with various levels within the organization and influence cross functionally.
  • Developing, maintaining, tracking, and managing high quality, integrated plans to enable accurate reporting and decision making

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

By using this website, you consent to the use of cookies in accordance with the privacy policy Ok, got it