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QC Validation Scientist

  • Job
    Full-time
    Senior Level
  • Science
    Healthcare

AI generated summary

  • You need expertise in method development/validation, QC testing, stability studies, cleaning validation, GMP compliance, and strong leadership in a chemistry lab for QC documentation and assessments.
  • You will oversee QC processes for new products, manage method validation, lead stability testing, ensure GMP compliance, and train staff while preparing necessary documentation and assessments.

Requirements

  • Method development (ICH Q14)
  • Analytical method validation (ICH Q2)
  • Technology/method transfer
  • QC stability testing (ICH Q1)
  • Ongoing stability studies
  • Formulation studies
  • Sampling plans
  • Cleaning validation (residue testing) methods
  • Routine use and validation of working standards
  • Management of reference and retention samples for finished products and raw materials
  • Implement QC policies to ensure compliance with Good Manufacturing Practices (GMP).
  • Support the management of contractors for outsourced QC Chemistry work.
  • Lead the qualification, planned preventative maintenance (PPM), and servicing of QC chemistry equipment.
  • Manage the chemistry laboratory staff on a day-to-day basis and for long-term planning. Lead training initiatives for QC scientists in relevant QC methods.
  • Prepare And Implement QC Documentation Such As
  • Protocols for stability studies, investigational work, and validations
  • QC reports, worksheets, SOPs, stability plans
  • 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 assessments on Change Control

Responsibilities

  • Oversee New Product Introduction Processes From a QC Perspective For Products To Be Manufactured In The Medicines Manufacturing Centre (MMC). This Includes
  • Method development (ICH Q14)
  • Analytical method validation (ICH Q2)
  • Technology/method transfer
  • QC stability testing (ICH Q1)
  • Ongoing stability studies
  • Formulation studies
  • Sampling plans
  • Cleaning validation (residue testing) methods
  • Lead The QC Reference Standards Processes, Including
  • Routine use and validation of working standards
  • Management of reference and retention samples for finished products and raw materials
  • Implement QC policies to ensure compliance with Good Manufacturing Practices (GMP).
  • Support the management of contractors for outsourced QC Chemistry work.
  • Lead the qualification, planned preventative maintenance (PPM), and servicing of QC chemistry equipment.
  • Manage the chemistry laboratory staff on a day-to-day basis and for long-term planning. Lead training initiatives for QC scientists in relevant QC methods.
  • Prepare And Implement QC Documentation Such As
  • Protocols for stability studies, investigational work, and validations
  • QC reports, worksheets, SOPs, stability plans
  • 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 assessments on Change Control

FAQs

What are the primary responsibilities of the QC Validation Scientist at the Medicines Manufacturing Centre?

The QC Validation Scientist will oversee new product introduction processes from a QC perspective, lead QC reference standards processes, implement QC policies to ensure compliance with GMP, manage contractors for outsourced QC Chemistry work, and prepare and implement various QC documentation.

What qualifications or experience are required for this role?

Candidates should have relevant experience in quality control and validation within a pharmaceutical environment, particularly relating to method development, analytical method validation, and compliance with GMP regulations.

What is the location of the Medicines Manufacturing Centre?

The Medicines Manufacturing Centre is located in Seaton Delaval, Northumberland, within the Northumbria Innovation and Manufacturing Hub.

What investment has been made in the Medicines Manufacturing Centre?

The Medicines Manufacturing Centre has received a £30 million investment from NHS England to support its development and operations.

What types of products will the facility manufacture?

The facility will focus on high-quality, regionally manufactured Ready-to-Administer (RtA) medicines and advanced aseptic products, particularly for oncology and other high-risk therapies.

How does the MMC prioritize quality and patient safety?

The MMC places quality, patient safety, and staff wellbeing at the core of its operations, with a leadership team committed to building a culture of openness, learning, and continuous improvement.

Who should I contact for further details or informal visits regarding the job?

You can contact Carly McGurty, the Deputy Head of Quality, via email at carly.mcgurty@nenc-mmc.nhs.uk for further details or to arrange an informal visit.

Will there be opportunities for training and development?

Yes, the role includes leading training initiatives for QC scientists in relevant QC methods, ensuring ongoing professional development within the team.

How will job security be maintained if the service is transferred to alternative ownership?

Employees with start dates prior to the transfer date will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE), preserving their terms and conditions and continuity of employment.

What methodologies does the QC Validation Scientist need to be familiar with?

The QC Validation Scientist should be familiar with methodologies such as ICH Q14 for method development, ICH Q2 for analytical method validation, ICH Q1 for QC stability testing, and techniques for cleaning validation and root cause analysis.

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.