Validation and Engineering Services QA Lead

Site Name: UK - Hertfordshire - Ware RD, UK - Hertfordshire - Stevenage
Posted Date: Mar 3 2025

Are you a Quality Assurance or Validation Professional seeking an opportunity to leverage and/or build upon your expertise in Quality Assurance and/or Validation (inclusive of equipment, utilities, facilities, computer systems, vendor management) working with internal and external business partners for R&D?

Do you enjoy a varied day dealing with challenges and answering the call for advice on different scenarios? If yes, the Validation and Engineering Services QA Lead role in Quality R&D Operations may be the right opportunity for you to explore.

This is a great opportunity where you will deal with various situations, which you will need to provide solutions for. Within QA you will be presented with issues and business proposals which you will be asked your advice to ensure quality and the patient is not affected while allowing us to grow and develop as a competitive business.

You will work cross functionally with different teams, gaining experience of providing key project management direction, pilot plant systems, medical devices, utilities and facilities.

This role can either be Validation focus or Engineering Services focus based on candidate's experience.

In this role you will perform the quality assurance activities and quality oversight of GMP Engineering Services activities (calibration, PM, Capital Project management, third party assessments etc.) and Scientific Services (Calibration, PM of Analytical Equipment) performed within UK Pharma R&D sites globally.

• Lead or support continuous improvement initiatives to align validation activities across Vx/Rx R&D Sites.
• Provide advice and consultancy to validation strategy for Capital Projects to ensure compliance with GSK GQP requirement, regulatory requirements and industry standards.
• Support gap assessments for new Global Quality Policy (GQP) or GQP revisions relating to System Qualification, Facility Design, Facility Operation, Compressed Gases, or Water/Steam.
• Provide quality oversight of R&D Engineering Services (RDES) and Scientific Services (SS) at multiple R&D GMP Sites, including:
• Review and approval GMP operational procedures (SOP or Work Instruction), Review and approval new equipment/instrument setup or change forms
  • Review and approval engineering change control
  • Support quality deviation investigation associated with service failures.
  • Support internal and external audits/assessments
  • Manage third party supplier assessment and vendor complaints for RDES external service providers.

Why you?
Essential Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in a science, engineering, or life sciences from an accredited university.
• Experiences in the pharmaceutical industry working to cGMP standards in Quality or Validation.
• Validation Experience with one of the three validation focuses: Facility/Utilities/Equipment, Computer System Validations, or Cleaning Validation.
• Experience in third party supplier assessment for engineering services.
• Experience with key Quality activities (i.e. Deviations, Customer complaints and Change Control, vendor complaints, vendor assessments)
• Strong interpersonal skills plus strong written and verbal communication skills.
• A good team player and able to work independently.

Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:

• Master's Degree in Pharmacy, Science, or an engineering discipline
• Good understanding of instrument calibration and equipment preventative maintenance programs
• Subject Matter Expert in the design and qualification of GMP utilities (HVAC, WFI, Clean Steam), Computer System or Cleaning Validation
• Familiarisation with Data Integrity principles (ALCOA+).
• Good analytical and problem-solving skills
• Experience of working with multi-functional teams with excellent organizational skills
• Strong interpersonal skills plus strong written and verbal communication skills.
• A good team player and able to work independently.

Closing Date for Applications - 17/03/2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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