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Mylan

Technical Development Analyst

Mylan

  • Dublin
  • Not disclosed
  • Fixed term contract
  • Updated 08/02/2013
  • HR
this job is expired
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Description

Technical Development Laboratory Analyst - Gerard Laboratories. Analytical Chemist

 

 

Job Title:             Technical Development Analyst

Contract:             6 to 11 months

Reporting to:      Technical Development Team Leader(TL)/ Supervisor

Main Objectives:

  •     To carry out analytical testing on samples to support the activities of the Technical Development  Dept.
  •     To provide technical support as required by management.

 Main Duties:

  •  Perform analytical testing and investigative work utilising HPLC, GC, Particle Size and Dissolution techniques as scheduled by Teamleader  (TL)/Supervisor.
  •  Perform method development and validation of analytical methods
  •  To troubleshoot problem methods and processes.
  •  To maintain all laboratory notebooks, records, chromatograms to an acceptable cGLP standard.
  •  To maintain and follow all relevant Standard Operating Procedures.
  •  To calibrate and maintain all designated laboratory instruments.
  •  To bring to the notice of the TL or Supervisor any discrepancies, deviations or non-conformances in      testing or work practices.
  •   To follow current analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  •   Perform sampling of validation batches.
  •   To carry out documentation review as required.
  •   Support the implementation of the Operational Excellence Programme on-site by identifying and   implementing improvements.
  •   Handle Controlled Drugs in accordance with procedures and legal requirements.
  •   Adhere to all company and legislative health, safety and environmental requirements.

Requirements:

  • 3rd level qualification in science related discipline
  • At least 3 years industrial experience  working in a cGLP/cGMP environment
  • Experience in the following analytical techniques is essential: HPLC, GC, Particle Size and  Dissolution testing
  • Experience in method development and method validation is essential
  • Thorough knowledge of all relevant ICH guidelines and Pharmacopoeias
  • Strong organisational skills / ability to prioritise work.
  • Good verbal and written communication skills
  • Excellent troubleshooting and problem solving skills with good attention to detail
  • Ability to think logically and be proactive.
  • Ability to work as part of a team and on own initiative in a constructive manner
  • Flexible and self motivated

Ref: TDD AnalystC
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