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QC Graduate Role

General ElectricCarrigtohill, T45 Av60, CorkGraduate

JOB DESCRIPTION

Job Description Summary

QC graduate

Job Description

Finished Product

Graduate role specific:

•FP team project & Testing Support

•Running Team Boards & Metrics

•Shadowing PTL and acting as designee.

•Ownership of TW records, attending IRB, deviation reduction plans, GMP slide preparation

•Shadow Lead specialist and run team meetings

•Support a specialist project- transfers, method validation etc.

• Leading a QC Improvement Project

Roles and Responsibilities

  • Carry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodine, Thin Layer Chromatography, Free aromatic amines, pH, RI, Trom’s, EDTA, Technical tests, Extractable volume., complaints etc..
  • Assisting in the maintenance of the stability program
  • Actively involved in Investigations e.g. LIR’s. etc..
  • Logging of samples in LIMS
  • Entering results on LIMS, checking results are within specification and also task approval.
  • Ensure compliance with EHS at all times, actively participate in EHS activities.
  • Perform routine instrument calibration checks at appropriate times.
  • Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times.
  • Completion of Documentation for Batch Release process.
  • Assisting in the provision of trends, CPV etc..
  • Assist in audits.
  • Generation/ reporting of Key performance indicators for the group.
  • Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
  • Interaction with other departments e.g. QA, BU, Sterility assurance etc.
  • Keep colleagues informed of current issues and developments as appropriate.
  • Reasonable level of overtime will be required to facilitate the business needs.
  • Carry out additional duties as deemed necessary by your Group Leader/ Supervisor.

Required Qualifications

  • A third level Science Qualification

Desired Characteristics

  • Strong oral and written communication skills. Ability to document, plan, market, and execute programs.
  • Pharmaceutical experience in a GMP regulated laboratory environment.

Additional Information

Relocation Assistance Provided: No

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