QC - Quality Analytical Services

Role Description

Pfizer Grange Castle - QC Analyst 

Job Title: QC Analyst – Quality Analytical Services
Department: Quality Control
Position Reports to: QC Supervisor

Job Purpose:
• This position provides support to the QC test labs to facilitate the routine testing of the products and systems on site.

Job Responsibilities:

Technical
• Perform media performance qualification of all lots, deliveries and media types delivered to site to support the Microbiological monitoring of our processes, manufacturing areas and systems on site.
• Run and maintain the associated documentation for the autoclave of qualified and waste loads in the quality building.
• Raise and process all consumable orders required to support the routine running of the test labs.
• Perform standardization of all pipettes for the QC test labs.
• Prepare all solutions that are required to allow routine testing to be performed.
• Will be responsible for performing all cleans associated with the QC equipment in the QC test labs.
• Perform annual re-verification of the decontamination autoclaves in the test labs.
• Maintain the Quality Analytical Services Lab in a state of audit readiness at all times.
• Participate in new initiatives such as the 5S, Standard Work and Data Integrity programs as they arise.
• Participate in and drive the continuous improvement of all aspects of the QAS group.

Documentation
• Revise and generate new SOP’s as required.
• The writing of risk assessments and Change Controls as required to introduce new improvements to the QAS group.

Training
• Keep training records up to date including scheduling of training in SOP revisions and completion of relevant training curricula.

GMP/Safety
• Establishment and implementation of appropriate levels of cGMP within the areas of work.
• Implement and adhere to cGMP regulations and company policies.
• Promotion of safety awareness within designated function.

Education/Experience:
o Relevant Third Level Qualification or Equivalent
o One to two years relevant experience in the pharmaceutical industry is preferable but not mandatory.

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