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Stability Co-ordinator

Job Seekers Ireland Science Life Science

Job Summary

  • Waterford
  • Permanent
  • BBBH814935
  • May 16, 2022
  • Competitive
Job Description

Minimum of Bachelor's degree in pharmaceutical sciences/chemistry or chemical/bioengineering and 5-years' experience in the pharmaceutical industry required.

The Position

The Stability Co-ordinator reports to the Associate Director, Analytical Laboratory and has overall responsibility for all stability programs. The candidate will be responsible for generating and reviewing all stability related documents, policies, protocols etc. The candidate will be an integral part of the day to day operation of the Analytical laboratory and supporting site activities. The candidate will help prepare and maintain an inspection ready status within the laboratory to support regulatory audits. Previous experience of managing stability programs is high desirable.

Responsibilities

  • To author all stability related documents and protocols and ensure all documents are approved prior to study initiation.

  • To review the analytical data generated during the stability program and highlight any non-compliances in a timely manner.

  • To provide stability data to other departments as required.

  • To order stability chambers and related equipment, as needed.

  • To maintain stability chamber inventory and monitor chamber performance.

  • To remove samples from chambers according to protocol pull schedules and submit to analytical laboratory for testing.

  • To liase with external contract stability storage facility as appropriate.

  • To perform routine analytical activities, as required, to support day to day laboratory operations.

  • To be actively involved in internal investigations e.g. Laboratory Out of Specifications, Incidents & Deviations etc.

  • To ensure that all work is carried out in compliance with the required company standards and conforms to cGxP, relevant SOPs, safety and environmental guidelines.

  • To identify continuous improvement opportunities.

  • To Implement Health & Safety requirements as per site documentation including SOPs, Safety Statement

  • Report any defects or potential hazards.

    Qualifications and Skills Required:

  • Minimum of Bachelor's degree in pharmaceutical sciences/chemistry or chemical/bioengineering.

  • 5-years' experience in the pharmaceutical industry.

  • Experience in managing stability programs is highly desirable.

  • Data analysis and presentation skills.

  • Problem solving skills.

  • Sterile/Biologics experience required.

  • Understanding of US, EU, and ICH Good Manufacturing Practices regulation concepts

  • Strong and effective interpersonal skills and demonstrated leadership in a fast-paced company.

  • Team player.

  • Ability to communicate clearly and concisely verbally and in writing.

  • Working in the Laboratory as and when required.

The Person:

This role requires the ability to be able to work in a fast-paced analytical laboratory. You need to be a self-starter who can work effectively both independently and as part of a team. You must show good judgment and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.

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

Carly Crosby
Carly Crosby
  • Consultant | Science Recruitment
  • 353 (0) 21 2300300
  • ccrosby@morganmckinley.com