QA Representative

  • Cork
  • Permanent
  • JO-1908-64679_1567438971

Summary

Responsibilities:

  • Provides quality leadership, direction, and governance for the specific area of responsibility.
  • Is responsible for approving appropriate quality-related documents.
  • Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices & promptly report any safety concerns.
  • Perform ongoing monitoring that includes
    • Monitoring of quality systems,
    • Production area time on floor audits,
    • Verification of the effective implementation of key GMP programs,
    • Review of systems that impact product quality to ensure that they operate in a state of control.
  • Provide QA ownership for products manufactured in the area of responsibility.
  • Provide coaching and mentoring to operations personnel and to other QA reps on appropriate risk management to provide appropriate and timely solutions to compliance in a business-focused fashion.
  • Maintenance of all aspects of GMP compliance for the area(s) of responsibility.
  • Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
  • Review and approval of change controls, observations, deviations, suspect analytical results and product quality complaints associated with the area(s) of responsibility.
  • Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
  • Audit and participation in the site self-inspection program.
  • Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility
  • Contribution to Annual Product Reviews, US Annual Reports, and Regulatory Submissions.
  • Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA's.

Requirements:

  • BSc/MSc/PhD in Chemistry, Microbiology, Biochemistry, Biotechnology or a Science related subject.
  • Additional Skills/Preferences
  • Demonstrated excellent technical and problem-solving skills.
  • Demonstrated strong interpersonal skills.
  • Demonstrated strong verbal and written communication skills.
  • Demonstrated ability to participate in and facilitate decision-making.
  • Good IT skills and knowledge of standard software packages (e.g. Microsoft Word, Excel, SAP, Darwin)
  • Demonstrated good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines.
  • Demonstrated initiative - able to work proactively without direct supervision, continuous improvement mind-set.
  • Minimum of 2 years experience (associate to mid-level) as a QA Representative supporting Small Molecule production. Excellent understanding of the current pharmaceutical industry regulations (e.g. FDA, EU, ICH).

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