Quality Documentation Specialist (Shift)

  • Contract
  • Cork

Website Ref:TPM04677

Summary:
A Quality Documentation Specialist is required for a biopharmaceutical company in West Cork. The incumbent will support activities relating to Quality Documentation System on site. This is a shift role.

Responsibilities:

  • Provides to the site knowledge and experience in Quality Documentation Systems.
  • Responsible for the Site Documentation System including Issuance, reconciliation, storage, archiving and retrevial of cGMP documentation to support the manufacture & testing of our products.
  • Responsible for maintaining the Site Master file for current effective cGMP documents on site.
  • Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement and execute tasks.
  • Provides compliance contribution to project teams and leads small projects.
  • Complete documentation audits.
  • Coaches and guides colleagues within the site.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Responds to non-standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Ensures supply of high quality product through the implementation and oversight of the Quality Documentation System for the site.
  • Champion the highest Quality and Compliance standards for the site.
  • Ensure highest safety standards.
  • Additional activities as requested by QA Lead.

Qualifications & Experience:

  • Relevant degree.
  • 1-2 years pharmaceutical / documentation experience.
  • Experience in a similar regulated documentation role is strongly preferred.
  • cGMP documentation control SME knowledge, from both operational and educational experience, is required.
  • Must possess excellent communication skills (verbal & written).
  • Must have excellent organizational (Time Management) skills, attention to detail and computer skills including Excel, Word and Sharepoint.
  • Be able to work as a flexible member of a Quality team.
  • Ability to collate and control GMP documentation.
  • Demonstrated ability to drive the completion of tasks.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Desirable evidence of Continuous Professional Development.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.