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Quality Systems Specialist

  • Location: La Verne
  • Salary: US$27 - US$29 per hour per hour
  • Job Type:Contract

Posted 18 days ago

  • Sector: Life Sciences
  • Contact: Mark Watson
  • Duration: 6 Months
  • Expiry Date: 08 October 2022
  • Job Ref: JN -092022-473632

On-site opportunity to work within a leading pharmaceutical company on an initial 6-Month contract (with scope for extension)

Do you, or someone you know, have strong knowledge of GMPs and an affinity for software & systems? This role could be a great fit for you!

Key Responsibilities:

* Conducts a comprehensive and critical evaluation of Laboratory records including but not limited to content, results, data accuracy and scientific relevance, format and adherence to GMP.

* Performs a thorough review of raw data and documentation to ensure compliance to applicable specifications and protocols.

* Supports the laboratory testing group instrument qualification and method validation review.

* Performs procedural and method revisions, where necessary.

* Conducts GMP review of laboratory notebooks, logbooks and associated forms including electronic raw data to ensure compliance with data integrity.

Key Requirements/Preferences:

* Advanced knowledge of current Good Manufacturing Practices (GMPs), pharmacopeia and compendial requirements, and pharmaceutical industry practices.

* Strong knowledge of regulatory requirements surrounding Data Integrity.

* Familiarity of analytic testing methods and validation including laboratory instrumentation.

Please apply with your most up-to-date resume to be considered.