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Job Location drjobs

Cork - Ireland

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Description Summary

To provide Quality Control support during batch manufacture and filling process across the In Process lab.

Job Description

MAIN RESPONSIBILITIES

Graduate role specific:

  • In Process Testing Support e.g. MET BU etc
  • Running Team DMS Board at Tier 1
  • Supporting EM programme
  • Consumable management
  • 5S support

Roles and Responsibilities:

  • Providing QC support during batch manufacture ensuring turnaround times are achieved as outlined in QC/Production Service Level Agreement and product release times.
  • This includes In process Chemistry/Microbiological analysis finished product Chemistry/Microbiological analysis.
  • WFI & Steam sampling and analysis
  • Water collection
  • Actively involved in Investigations e.g. Batch Corrections EMI Bioburden etc
  • Performing routine instrument calibrations and calibration checks.
  • Routine validation and maintenance of equipment
  • Ensuring compliance with cGMP EHS GxP etc guidelines at all times.
  • Entering and approving results on LIMS/MODA & completion of batch documentation
  • Assisting with audits as required.
  • Assisting with 5S of In Process Lab.
  • Consumable management ordering stock take and following up with vendors on expected delivery times etc.
  • Supporting logbook review and archiving for In Process.
  • Ensure compliance with current pharmacopoeia and all regulatory/company guidelines.
  • Interaction with other departments e.g. Production Engineering QA.
  • Assisting in the training and up skilling of colleagues where possible.
  • Liaising with internal and external customers in relation to QC/Production issues
  • Any other duties as required by QC PTL and/or designee.

PRINCIPAL QUALIFICATIONS:

A third level Science Qualification

Skills REQUIRED:

Good communications skills excellent time management skills flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations.

DESIRED WORK EXPERIENCE:

Pharmaceutical experience in a GMP regulated laboratory environment.

Additional Information

Relocation Assistance Provided: No

Employment Type

Full-Time

Company Industry

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