Stability Coordinator

  • Cork
  • Contract 12 months
  • JO-1907-64650_1567421766

Summary

We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.

Responsibilities

The role potentially will cover both Analytical and Microbiological samples and testing including but not limited to the following:

* Contribute to selection of intermediate and product lots produced for stability studies.

* Coordinate and contribute to the scheduling of stability testing in QC.

* Trend stability data and report on same.

* Prepare stability related protocols, summaries, and reports - often for direct submission to pharmaceutical regulatory agencies.

* Coordinate movement and storage of samples for testing within QC, on site and to and from contract laboratories.

* Act as technical resource (SME) and train other analysts in areas of expertise.

* Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents.

* Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.

* Interact directly with regulatory agency inspectors during audits.

Requirements

* Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required.

* Good project management skills.

* Experience in presenting to senior management.

* Lead from front attitude.

* Knowledge of regulatory guidelines and directives.

* Data orientated with good risk management understanding.

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

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'Not Just Placers.........Partners'

The Life Science Specialists

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