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Quality Control Lead Scientist Microbiology

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Northumbria Healthcare NHS Foundation Trust

12d ago

  • Job
    Full-time
    Senior Level
  • Science
    Healthcare
  • Newcastle

AI generated summary

  • You must oversee NPI processes, develop methods, manage documentation, ensure GMP compliance, train staff, and perform QC assessments and data analysis in microbiology.
  • You will oversee microbiology QC for NPI processes, manage documentation, lead staff training, conduct method validation, OOS investigations, and analyze QC data to ensure compliance with GMP.

Requirements

  • Oversee The New Product Introduction (NPI) Processes From a Microbiology QC Perspective, Ensuring Successful Implementation For Products To Be Manufactured In The Medicines Manufacturing Centre (MMC). This Includes
  • Method development
  • Analytical method validation
  • Technology/method transfer
  • Reference standards management
  • Sampling and QC stability testing
  • Ongoing stability studies
  • Supervise QC Microbiology Testing For
  • Components and packaging
  • Raw materials
  • In-process testing
  • Finished products
  • Environmental monitoring samples
  • Implement QC Microbiology policies and processes that comply with Good Manufacturing Practice (GMP) and data integrity requirements.
  • Oversee and manage QC Microbiology documentation, ensuring all records are up to date and comply with regulatory requirements.
  • Lead training for QC Microbiology staff, ensuring they are proficient in relevant QC methods and regulatory standards.
  • Prepare And Implement QC Microbiology Documentation Such As
  • Worksheets, SOPs, and stability plans
  • QC reports
  • Statistical analysis
  • Perform Assessments For The Pharmaceutical Quality System (PQS), Including
  • Out of Specification (OOS) investigations
  • Root Cause Analysis (RCA)
  • Quality Risk Assessment (QRA)
  • QC assessment on Change Control
  • Perform QC data recording, trending, and statistical analysis for QC microbiology data, and track Key Performance Indicators (KPIs).

Responsibilities

  • Oversee The New Product Introduction (NPI) Processes From a Microbiology QC Perspective, Ensuring Successful Implementation For Products To Be Manufactured In The Medicines Manufacturing Centre (MMC). This Includes
  • Method development
  • Analytical method validation
  • Technology/method transfer
  • Reference standards management
  • Sampling and QC stability testing
  • Ongoing stability studies
  • Supervise QC Microbiology Testing For
  • Components and packaging
  • Raw materials
  • In-process testing
  • Finished products
  • Environmental monitoring samples
  • Implement QC Microbiology policies and processes that comply with Good Manufacturing Practice (GMP) and data integrity requirements.
  • Oversee and manage QC Microbiology documentation, ensuring all records are up to date and comply with regulatory requirements.
  • Lead training for QC Microbiology staff, ensuring they are proficient in relevant QC methods and regulatory standards.
  • Prepare And Implement QC Microbiology Documentation Such As
  • Worksheets, SOPs, and stability plans
  • QC reports
  • Statistical analysis
  • Perform Assessments For The Pharmaceutical Quality System (PQS), Including
  • Out of Specification (OOS) investigations
  • Root Cause Analysis (RCA)
  • Quality Risk Assessment (QRA)
  • QC assessment on Change Control
  • Perform QC data recording, trending, and statistical analysis for QC microbiology data, and track Key Performance Indicators (KPIs).

FAQs

What is the location of the Medicines Manufacturing Centre (MMC)?

The MMC is located in Seaton Delaval, Northumberland.

What qualifications are required for the Quality Control Lead Scientist Microbiology position?

While the job description does not specify exact qualifications, candidates typically need a strong educational background in microbiology or a related field, along with relevant experience in quality control and microbiological testing.

What type of facility is the MMC?

The MMC is a cutting-edge NHS pharmaceutical production facility designed to manufacture Ready-to-Administer (RtA) medicines and advanced aseptic products.

What are the expected responsibilities of the Quality Control Lead Scientist Microbiology?

Responsibilities include overseeing new product introduction processes, supervising QC microbiology testing, implementing QC policies, managing documentation, leading training for staff, and performing assessments for the pharmaceutical quality system.

What is the significance of GMP and data integrity in this role?

GMP (Good Manufacturing Practice) and data integrity are crucial for ensuring that pharmaceutical products are consistently produced and controlled according to quality standards. The Quality Control Lead Scientist must implement processes that comply with these regulations.

Is this position part of the Northumbria Healthcare NHS Foundation Trust?

Yes, all employees of the Medicines Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust.

What is the anticipated timeline for the MMC's construction and operation?

The facility construction is planned through to September 2025, and it is in the final design stages.

Are there training opportunities for staff within the MMC?

Yes, the Quality Control Lead Scientist will lead training for QC Microbiology staff to ensure proficiency in relevant QC methods and regulatory standards.

How can interested candidates get more information about the position?

Interested candidates can contact Carly McGurty, the Deputy Head of Quality, at carly.mcgurty@nenc-mmc.nhs.uk for further details or informal visits.

What type of investment has been made in the Medicines Manufacturing Centre?

The MMC has received £30 million of investment from NHS England to support its establishment and operation.

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Northumbria Healthcare NHS Foundation Trust

People Caring for People

Science & Healthcare
Industry
5001-10,000
Employees
2006
Founded Year

Mission & Purpose

Northumbria Healthcare NHS Foundation Trust provides a range of healthcare services across Northumberland and North Tyneside. Their ultimate mission is to deliver exceptional care and improve the health and well-being of the communities they serve. Their purpose is to offer high-quality, patient-centered care through their hospitals and community services, focusing on innovation, efficiency, and compassionate treatment.