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Stability Technician

Eingestellt von Radiant Info

Gesuchte Skills: Support

Projektbeschreibung

POSITION: STABILITY TECHNICIAN

LOCATION: SPEKE UK

CONTRACT LENGTH: 1 YEAR

MAIN DUTIES AND RESPONSIBILITIES:

STABILITY TECHNICIAN

GROUP STRUCTURE:

- 1 SENIOR ANALYST
- 2 STABILITY TECHNICIANS

REPORTS TO: QA GROUP LEADER

JOB PURPOSE:

The Stability Technician has the responsibility for executing the Speke site Stability programme to the standard expected by Lilly and by external regulators. Data from the Stability programme demonstrates the marketed products meet label claim at shelf life as required by law and is also used on an ongoing basis to support registration of Lilly products world wide.

Responsibilities include:

- Physical inspections of the samples, eg checking of any colour/texture changes and record observations
- Generate, update and control stability protocols, ensuring their standardisation and compliance to Company procedures and policies.
- Create, establish and maintain tracking systems for all appropriate documentation.
- Liaise with external Laboratories in the development of sample testing schedules and protocols.
- Coordinate the issuing of samples to ensure that all testing (internal and external) is performed as per their protocols and within agreed timelines.
- Electronic systems (LIMS) - study entry, result entry, verification, collecting data, setting up, formatting and printing reports in Lilly systems.
- Receive samples from production, prepare and store in compliance with Stability protocol, GMP and safety requirements.
- Note: some premix samples need to be riffled at each time interval and this requires advanced planning.
- Remove samples from storage at specified time points and issue to relevant areas for testing.
- Issuing stability reports to the Quality and/or Regulatory groups as required.
- Monitor the climatic rooms and storage facilities and take necessary action in the event of an excursion.

KEY SKILLS

- Attention to detail
- Demonstrated ability to work with complex data handling electronic systems
- Experience of working in a heavily regulated environment, ideally GMP
- Although laboratory experience is not necessary, there is an amount of sample handling required that might suit an individual who has had some laboratory experience.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Radiant Info